15 results
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15ms
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Sources: EU EUDAMED, US FDA
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MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria
FDA Enforcement
Class II
·Terminated·Beckman Coulter, Inc.·May 6, 2015
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·November 19, 2014
MicroScan Neg MIC 3J REF C54814
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·April 15, 2026
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·April 1, 2026
MicroScan Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·April 15, 2026
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 55, Catalog B1017-409 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Terminated·Beckman Coulter, Inc.·May 6, 2015
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 61, Catalog B1017-414 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Terminated·Beckman Coulter, Inc.·May 6, 2015
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg Combo 50, Catalog B1017-406 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Terminated·Beckman Coulter, Inc.·May 6, 2015
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/Urine Combo 51, Catalog B1017-407 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Terminated·Beckman Coulter, Inc.·May 6, 2015
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg/BP Combo 47, Catalog B1017-417 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Terminated·Beckman Coulter, Inc.·May 6, 2015
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Breakpoints Panel: Neg MIC 38, Catalog B1017-412 Microbiology: For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.
FDA Enforcement
Class II
·Terminated·Beckman Coulter, Inc.·May 6, 2015
CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA 21-2111-0300-09_FUK CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO 21-2111-0300-09_KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA 21-2111-0300-09_OKA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA 21-2111-0300-09_OMI CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA 21-2111-0300-09_OSA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO 21-2111-0300-09_SAP CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO 21-2111-0300-09_TOK CADD_SOLIS_MODEL 2110_ENGLISH_1/EA 21-2111-0200-50JP CADD-Solis VIP CADD-SOLIS V4.2 LOAN FUK 21-2111-0402-09-FUK CADD-SOLIS V4.2 LOAN NAG 21-2111-0402-09-NAG CADD-SOLIS V4.2 LOAN OKA 21-2111-0402-09-OKA CADD-SOLIS V4.2 LOAN OSA 21-2111-0402-09-OSA CADD-SOLIS V4.2 LOAN SAI 21-2111-0402-09-SAI CADD-SOLIS V4.2 LOAN SAP 21-2111-0402-09-SAP CADD-SOLIS V4.2 LOAN TOKE 21-2111-0402-09-TOKE CADD-SOLIS V4.2 LOAN TOKW 21-2111-0402-09-TOKW CADD-SOLIS V4.2 LOAN YELLOW KYO 21-2112-0402-09-KYO CADD-SOLIS V4.2 LOAN YELLOW NAG 21-2112-0402-09-NAG CADD-SOLIS V4.2 LOAN YELLOW YOK ¿ 21-2112-0402-09-YOK CADD-SOLIS V4.2 LOAN YOK 21-2111-0402-09-YOK Number:21-2111-0403-02Part Type:List Number/Finished GoodLifecycle Phase:03-ReleasedDescription:PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, FRENCH, 1/EA 21-2111-0403-02 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, YELLOW, ENGLISH, 1/EA 21-2112-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA 21-2111-0300-00 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DANISH 1/EA ¿ 21-2111-0300-12 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DUTCH 1/EA ¿ 21-2111-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, FRENCH 1/EA ¿ 21-2111-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, GERMAN 1/EA ¿ 21-2111-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, ITALIAN 1/EA ¿ 21-2111-0300-07 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, JAPANESE 21-2111-0300-09JP PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, FRENCH 1/EA ¿ 21-2111-0300-232 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA ¿ 21-2111-0300-231 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, SWEDISH 1/EA 21-2111-0300-244 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA ¿ 21-2111-0300-50 Not PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, PORTUGUESE 1/EA ¿ 21-2111-0300-17 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SPANISH 1/EA ¿ 21-2111-0300-08 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SWEDISH 1/EA ¿ 21-2111-0300-14 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, DUTCH 1/EA 21-2112-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, GERMAN 1/EA 21-2112-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA 21-2112-0300-00 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, DANISH 1/EA ¿ 21-2101-0200-12 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, FRENCH 1/EA ¿ 21-2101-0200-02 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, GERMAN 1/EA ¿ 21-2101-0200-03 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, ITALIAN 1/EA ¿ 21-2101-02
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·May 14, 2025
CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17, 21-2101-0200-238, 21-2101-249, 21-2101-51, 21-2102-0200-02, 21-2102-249, 21-2102-51, 21-2111-0100-00, 21-2111-0100-50, 21-2111-0100-51, 21-2111-0200-02, 21-2111-0200-03, 21-2111-0200-06, 21-2111-0200-07, 21-2111-0200-08, 21-2111-0200-12, 21-2111-0200-14, 21-2111-0200-17, 21-2111-0200-232, 21-2111-0200-50, 21-2111-0300-00, 21-2111-0300-01, 21-2111-0300-02, 21-2111-0300-03, 21-2111-0300-06, 21-2111-0300-07, 21-2111-0300-08, 21-2111-0300-09, 21-2111-0300-12, 21-2111-0300-14, 21-2111-0300-17, 21-2111-0300-231, 21-2111-0300-232, 21-2111-0300-50, 21-2111-0400-01, 21-2111-0400-51, 21-2111-0401-02L, 21-2111-0401-03L, 21-2111-0401-06L, 21-2111-0401-07, 21-2111-0401-07L, 21-2111-0401-08L, 21-2111-0401-12L, 21-2111-0401-14L, 21-2111-0401-17L, 21-2111-0401-249, 21-2111-0401-51, 21-2111-0401-51L, 21-2111-0401-78, 21-2111-0402-02, 21-2111-0402-02L, 21-2111-0402-03L, 21-2111-0402-06L, 21-2111-0402-07L, 21-2111-0402-08, 21-2111-0402-08L, 21-2111-0402-09_LOAN, 21-2111-0402-09-FUK, 21-2111-0402-09JP, 21-2111-0402-09-KYO, 21-2111-0402-09-NAG, 21-2111-0402-09-OKA, 21-2111-0402-09-OSA, 21-2111-0402-09-SAP, 21-2111-0402-09-SEN, 21-2111-0402-09-TOKE, 21-2111-0402-09-TOKW, 21-2111-0402-09-YOK, 21-2111-0402-12L, 21-2111-0402-14L, 21-2111-0402-17L, 21-2111-0402-249, 21-2111-0402-51, 21-2111-0402-51L, 21-2111-0402-78, 21-2112-0100-50, 21-2112-0100-51, 21-2112-0200-02, 21-2112-0200-06, 21-2112-0300-00, 21-2112-0300-01, 21-2112-0300-02, 21-2112-0300-03, 21-2112-0300-06, 21-2112-0300-231, 21-2112-0300-50, 21-2112-0400-01, 21-2112-0400-51, 21-2112-0401-02L, 21-2112-0401-03L, 21-2112-0401-07L, 21-2112-0401-08L, 21-2112-0401-17L, 21-2112-0401-51, 21-2112-0401-51L, 21-2112-0401-78, 21-2112-0402-02, 21-2112-0402-02L, 21-2112-0402-03L, 21-2112-0402-06L, 21-2112-0402-07L, 21-2112-0402-08L, 21-2112-0402-09JP, 21-2112-0402-09-SAI, 21-2112-0402-09-SEN, 21-2112-0402-09-TOKE, 21-2112-0402-17L, 21-2112-0402-249, 21-2112-0402-51, 21-2112-0402-51L, 21-2120-0100-02, 21-2120-0100-03, 21-2120-0100-06, 21-2120-0100-232, 21-2120-0100-233, 21-2120-0100-50, 21-2120-0100-51, 21-2120-0100-95, 21-2120-0102-02, 21-2120-0102-03, 21-2120-0102-06, 21-2120-0102-07, 21-2120-0102-08, 21-2120-0102-12, 21-2120-0102-13, 21-2120-0102-14, 21-2120-0102-15, 21-2120-0102-17, 21-2120-0102-247, 21-2120-0102-249, 21-2120-0102-51, 21-2120-0102-78, 21-2120-0102-92, 21-2120-0102-98, 21-2120-0103-01, 21-2120-0103-02, 21-2120-0103-03, 21-2120-0103-06, 21-2120-0103-07, 21-2120-0103-08, 21-2120-0103-14, 21-2120-0103-15, 21-2120-0103-17, 21-2120-0103-249, 21-2120-0103-51, 21-2120-0103-78, 21-2120-0104-01, 21-2120-0105-00, 21-2120-0105-01, 21-2120-0105-02L, 21-2120-0105-03L, 21-2120-0105-06L, 21-2120-0105-07L, 21-2120-0105-08L, 21-2120-0105-12L, 21-2120-0105-13L, 21-2120-0105-14L, 21-2120-0105-15L, 21-2120-0105-17L, 21-2120-0105-231, 21-2120-0105-50, 21-2120-0105-50L, 21-2125-0104-01, 21-2125-0105-07L, 21-2125-0105-08L, 21-2125-0105-50L, 21-2127-0104-01, 21-2127-0105-01, 21-2127-0105-02L, 21-2127-0105-03L, 21-2127-0105-06L, 21-2127-0105-08L, 21-2127-0105-50L, 22-4095-0203-51, 22-4095-0204-25, 22-4095-0205-25.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·November 6, 2024
Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) LACERATION TRAY , Pack Number DYNDL1062B ; 7) LACERATION TRAY , Pack Number DYNDL1073; 8) LACERATION TRAY , Pack Number DYNDL1076; 9) LACERATION TRAY , Pack Number DYNDL1090A ; 10) ER LACERATION TRAY, Pack Number DYNDL1096; 11) LACERATION TRAY , Pack Number DYNDL1151C ; 12) LACERATION TRAY , Pack Number DYNDL1152A ; 13) LACERATION TRAY , Pack Number DYNDL1152AH; 14) LACERATION TRAY , Pack Number DYNDL1159B ; 15) LACERATION TRAY , Pack Number DYNDL1163; 16) LACERATION TRAY , Pack Number DYNDL1163H ; 17) LACERATION TRAY , Pack Number DYNDL1171; 18) CUSTOM LACERATION TRAY, Pack Number DYNDL1177C ; 19) E. R. LACERATION TRAY , Pack Number DYNDL1187A ; 20) LACERATION TRAY , Pack Number DYNDL1208B ; 21) LACERATION TRAY, Pack Number DYNDL1223A; 22) LACERATION TRAY , Pack Number DYNDL1250C ; 23) LACERATION TRAY , Pack Number DYNDL1257A ; 24) LACERATION TRAY , Pack Number DYNDL1263A ; 25) TRAY,LACERATION , Pack Number DYNDL1271B ; 26) LACERATION TRAY , Pack Number DYNDL1284; 27) LACERATION TRAY , Pack Number DYNDL1285; 28) LACERATION TRAY , Pack Number DYNDL1366A ; 29) LACERATION TRAY , Pack Number DYNDL1368; 30) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377A ; 31) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377AH; 32) LACERATION TRAY , Pack Number DYNDL1399; 33) LACERATION TRAY , Pack Number DYNDL1403; 34) LACERATION TRAY , Pack Number DYNDL1406A ; 35) TRAY,LACERATION , Pack Number DYNDL1455; 36) LACERATION TRAY , Pack Number DYNDL1457; 37) TRAY LACERATION , Pack Number DYNDL1465; 38) LACERATION TRAY , Pack Number DYNDL1496; 39) LACERATION TRAY , Pack Number DYNDL1496H ; 40) TRAY,LACERATION , Pack Number DYNDL1510; 41) TRAY,LACERATION, Pack Number DYNDL1542; 42) TRAY,LACERATION , Pack Number DYNDL1542; 43) TRAY ER LACERATION, Pack Number DYNDL1569A ; 44) TRAY SM ER LACERATION , Pack Number DYNDL1573; 45) LACERATION TRAY , Pack Number DYNDL1575A ; 46) LACERATION TRAY , Pack Number DYNDL1628A ; 47) LACERATION TRAY , Pack Number DYNDL1634; 48) LACERATION PACK , Pack Number DYNDL1637A ; 49) LACERATION TRAY , Pack Number DYNDL1678; 50) LACERATION TRAY , Pack Number DYNDL1679B ; 51) LACERATION TRAY , Pack Number DYNDL1690; 52) ER LACERATION TRAY, Pack Number DYNDL1693; 53) LACERATION TRAY , Pack Number DYNDL1705; 54) LACERATION TRAY, Pack Number DYNDL1705H ; 55) SUTURE LACERATION KIT , Pack Number DYNDL1707A ; 56) LACERATION TRAY , Pack Number DYNDL1714; 57) LACERATION KIT, Pack Number DYNDL1717; 58) NMG LACERATION TRAY , Pack Number DYNDL1722; 59) LACERATION TRAY , Pack Number DYNDL1728; 60) LACERATION TRAY , Pack Number DYNDL1729; 61) LACERATION TRAY , Pack Number DYNDL1739; 62) LACERATION TRAY , Pack Number DYNDL1740; 63) LACERATION TRAY , Pack Number DYNDL1757; 64) LACERATION TRAY , Pack Number DYNDL1758; 65) LACERATION TRAY, Pack Number DYNDL1758H ; 66) LACERATION TRAY HIGH GRADE, Pack Number DYNDL1762; 67) LACERATION TRAY , Pack Number DYNDL1768; 68) LACERATION TRAY , Pack Number DYNDL1770B ; 69) LACERATION TRAY , Pack Number DYNDL1772; 70) LACERATION TRAY , Pack Number DYNDL1774A ; 71) LACERATION TRAY W/SAFETY NDLS , Pack Number DYNDL1783; 72) LACERATION TRAY , Pack Number DYNDL1790; 73) LACERATION TRAY , Pack Number DYNDL1838; 74) LACERATION TRAY , Pack Number DYNDL1870; 75) LACERATION TRAY , Pack Number DYNDL1870H ; 76) LACERATION TRAY , Pack Number DYNDL1872; 77) LACERATION TRAY W/ UNDERPAD , Pack Number DYNDL1878; 78) LACERATION TRAY , Pack Number DYNDL1887; 79) LACERATION TRAY , Pack Number DYNDL1888; 80) LACERATION TRAY , Pack Number DYNDL1892; 81) LACERATION TRAY , Pack Number DYNDL1920; 82) LACERATION TRAY W/ ADSON FCP, Pack Number DYNDL1923A ; 83) LACERATION TRAY
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024