BEUDAMED
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    Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. SHY IR PICC PACK, Model Number: DYNJ57112; b. STANDARD PICC II-LF, Model Number: DYNJSPICC2, PICCNC002; c. SUPERFICAL VENOUS PROCEDURE, Model Number: DYNJ82989; d. SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267; e. TV IR PICC PACK-LF, Model Number: DYNJ41561D; f. ULTASOUND GUIDED PIV INSERTION, Model Number: IVS3635A; g. ULTRASOUND GUIDED PIV KIT, Model Number: DYNDA2669; h. USG PIV INSERTION KIT, Model Number: DYNDV2480; i. VASCULAR, Model Number: DYNJ907965; j. VASCULAR ACCESS, Model Number: DYNJ901340A; k. VASCULAR ACCESS TRAY, Model Number: DYNJ52606B; l. VASCULAR ACCESS-LF, Model Number: DYNJ905285D; m. VASCULAR ENDO LASER PK, Model Number: DYNJ37445G; n. VASCULAR PACK, Model Number: DYNJ66356F; o. VASCULAR VEIN PACK, Model Number: DYNJ69769; p. VEIN ABLATION, Model Number: DYNJ63268C, DYNJ63268D, DYNJ66079A; q. VEIN ABLATION KIT, Model Number: DYNJ69272; r. VEIN ABLATION PACK, Model Number: DYNJ62889A, DYNJ62889B, DYNJ69288; s. VEIN ABLATION PLUS W CHL, Model Number: DYNJ67115A; t. VEIN CLOSURE, Model Number: DYNJ49180A; u. VEIN CLOSURE PACK, Model Number: DYNJ69976, DYNJ69976A, DYNJ81834; v. VEIN CLOSURE TRAY - NIVC, Model Number: DYNJ44737C; w. VEIN HARVESTING PACK, Model Number: DYNJ82933; x. VEIN LIGATION, Model Number: DYNJ64190B; y. VEIN OHH, Model Number: DYNJ65560C; z. VEIN PACK, Model Number: DYNJ66743B, DYNJ69091A, DYNJ69091B, DYNJ69177, DYNJ69942, DYNJ69942A, DYNJ81120, DYNJ81212A, DYNJ83914; aa. VEIN PACK-LF, Model Number: DYNJ66271B, DYNJ66271D; bb. VEIN PROCEDURE PACK, Model Number: DYNJ62038B, DYNJ81177; cc. VEIN PROCEDURE TRAY, Model Number: DYNJ82581; dd. VENCLOSE PROCEDURE PACK 7CM, Model Number: VC-PPH-6F7A; ee. VENCLOSE PROCEDURE PACK MAVEN, Model Number: VC-PPM-12F; ff. VENCLOSE PROCEDURE PACK, 12CM, Model Number: VC-PP-6F12, VC-PPH-6F12A; gg. VENOUS ABLATION, Model Number: DYNJ44904B, DYNJ44904C; hh. VENOUS ACCESS, Model Number: DYNJ59751B; ii. VENOUS ACCESS PACK, Model Number: DYNJ44421B; jj. VENOUS ACCESS TRAY, Model Number: DYNJ20094L; kk. VENOUS LIGATION PACK, Model Number: DYNJ43981G; ll. VENOUS PACK, Model Number: DYNJ43168, DYNJ43168A, DYNJ43168B, DYNJ56260A, DYNJ56447B, DYNJ62711A, DYNJ66499A, DYNJ66499B, DYNJ80169, DYNJ80169A, DYNJ80692; mm. VNUS PACK, Model Number: DYNJ59246A; nn. WEST VALLEY PICC LINE PACK, Model Number: DYNJ43975A;

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·August 9, 2023

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K; 5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L; 6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B; 8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D; 9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C; 10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G; 11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A; 12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C; 13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F; 14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501; 15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D.

    FDA Enforcement
    Class II ·Ongoing·Medline Industries, LP·May 6, 2026

    Medline custom medical procedure kits labeled as: 1) CRANI, REF CDS780089V; 2) CRANIOFACIAL CDS, REF CDS780102K; 3) CRANIOFACIAL CDS, REF CDS780102L; 4) CRANIOFACIAL CDS, REF CDS780102M; 5) CRANIOTOMY CDS-LF, REF CDS780105K; 6) CRANIOTOMY CDS-LF, REF CDS780105L; 7) CRANIOTOMY CDS-LF, REF CDS780105M; 8) NEURO CRANIOTOMY CDS #36-RF, REF CDS780119V; 9) CRANIOTOMY CDS, REF CDS780166Q; 10) ANTERIOR CERVICAL CDS, REF CDS780205O; 11) ANTERIOR CERVICAL CDS, REF CDS780205P; 12) ANTERIOR CERVICAL CDS, REF CDS780205Q; 13) CRANIOTOMY CDS, REF CDS780206O; 14) CRANIOTOMY CDS, REF CDS780206P; 15) CRANIOTOMY CDS, REF CDS780206R; 16) NEURO-LAMI CDS, REF CDS780208I; 17) SHY CRANIOTOMY CDS, REF CDS780214M; 18) SHY CRANIOTOMY CDS, REF CDS780214N; 19) SPINAL CDS, REF CDS940087AL; 20) ORTHO SPINE PROCEDURE, REF CDS940875P; 21) CRANIOTOMY-RICHMOND, REF CDS980929Q; 22) CRANIOTOMY-RICHMOND, REF CDS980929R; 23) CRANIOTOMY-RICHMOND, REF CDS980929S; 24) CRANIOTOMY-RICHMOND, REF CDS980929T; 25) CRANIOTOMY-RICHMOND, REF CDS980929U; 26) OMC LUMBAR CDS, REF CDS981062I; 27) LAMINECTOMY CDS, REF CDS981229A; 28) ORTHO SPINE SUPPLEMENTAL CDS, REF CDS981742M; 29) CRANIOTOMY CDS, REF CDS981888X; 30) ANTERIOR CERVICAL DISC, REF CDS982023S; 31) ANTERIOR CERVICAL DISC, REF CDS982023T; 32) CRANIOTOMY, REF CDS982029R; 33) CRANIOTOMY, REF CDS982029S; 34) LAMI FUSION, REF CDS982035T; 35) LAMI FUSION, REF CDS982035U; 36) MICRODISCECTOMY, REF CDS982054W; 37) CRANIOTOMY CDS, REF CDS982480L; 38) CRANIOTOMY CDS, REF CDS982480M; 39) CRANIOTOMY CDS, REF CDS982480N; 40) CRANIOTOMY CDS, REF CDS982480O; 41) CRANIOTOMY CDS, REF CDS982480P; 42) LAMINECTOMY CDS, REF CDS982491L; 43) LAMINECTOMY CDS, REF CDS982491M; 44) LAMINECTOMY CDS, REF CDS982491N; 45) LAMINECTOMY CDS, REF CDS982491O; 46) LAMINECTOMY CDS, REF CDS982491P; 47) LAMINECTOMY CDS, REF CDS982491Q; 48) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563C; 49) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563D; 50) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563F; 51) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563G; 52) MAJOR SPINE ORTHO/NEURO CDS, REF CDS982563I; 53) NEURO SPINE CDS, REF CDS982683O; 54) NEURO SPINE CDS, REF CDS982683P; 55) NEURO SPINE CDS, REF CDS982683R; 56) NEURO SPINE CDS, REF CDS982683S; 57) NEURO SPINE CDS, REF CDS982683U; 58) NEURO SPINE CDS, REF CDS982683V; 59) NEURO SPINE, REF CDS982683W; 60) CRANIOTOMY, REF CDS982719P; 61) CRANIOTOMY, REF CDS982719Q; 62) CRANIOTOMY, REF CDS982719R; 63) CRANIOTOMY, REF CDS982719S; 64) CRANIOTOMY, REF CDS982719T; 65) CRANIOTOMY, REF CDS982719U; 66) CRANIOTOMY, REF CDS982719V; 67) CRANIOTOMY, REF CDS982719W; 68) ORTHO SPINE, REF CDS982735M; 69) ORTHO SPINE, REF CDS982735N; 70) ORTHO SPINE, REF CDS982735O; 71) ORTHO SPINE, REF CDS982735Q; 72) ORTHO SPINE, REF CDS982735R; 73) ORTHO SPINE, REF CDS982735S; 74) ORTHO SPINE, REF CDS982735U; 75) SPINAL CDS, REF CDS983037J; 76) SPINAL CDS, REF CDS983037K; 77) CRANIOTOMY CDS, REF CDS983094D; 78) CERVICAL SPINE CDS, REF CDS983108F; 79) LAMINECTOMY CDS, REF CDS983115F; 80) ZALE SPINE CDS, REF CDS983182F; 81) ZALE SPINE CDS, REF CDS983182G; 82) ZALE SPINE CDS, REF CDS983182I; 83) ZALE SPINE CDS, REF CDS983182J; 84) ZALE SPINE CDS, REF CDS983182K; 85) ZALE SPINE CDS, REF CDS983182L; 86) ZALE SPINE CDS, REF CDS983182M; 87) ZALE CRANIOTOMY CDS, REF CDS983188F; 88) ZALE CRANIOTOMY CDS, REF CDS983188K; 89) CRANIOTOMY, REF CDS983349J; 90) CRANIOTOMY, REF CDS983349K; 91) CRANIOTOMY, REF CDS983349L; 92) CRANIOTOMY, REF CDS983349M; 93) CRANIOTOMY, REF CDS983349N; 94) CRANIOTOMY, REF CDS983349O; 95) CRANI CDS, REF CDS983386G; 96) CRANIOTOMY CDS, REF CDS983467D; 97) CRANIOTOMY CDS, REF CDS983467F; 98) CRANIOTOMY CDS, REF CDS983467G; 99) CRANIOTOMY CDS, REF CDS983467I; 100) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476D; 101) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476F; 102) LUMBAR LAMINECTOMY NEURO CDS, REF CDS983476G; 103) LUMBAR LAMINECTOMY NEURO CDS, REF CDS98

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·January 8, 2025

    Medline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2) PICC LINE TRAY, Pack Number 00-401993O ; 3) ARTERIOGRAM TRAY, Pack Number 00-402001T ; 4) ARTERIOGRAM TRAY, Pack Number 00-402001U ; 5) HEALTH LINE MAX BARRIER KIT , Pack Number A134-MAX ; 6) ART-LINE SURGERY PACK-LF, Pack Number ARTNC175 ; 7) AV FISTULA PACK , Pack Number CDS840188M ; 8) VP SHUNT, Pack Number CDS840193V ; 9) THROMBECTOMY/AV FISTULA CDS-LF, Pack Number CDS840295G ; 10) IVC PLACEMENT CDS-LF, Pack Number CDS860033A ; 11) IVC PLACEMENT CDS-LF, Pack Number CDS860033AH; 12) CENTRAL LINE CDS, Pack Number CDS930092V ; 13) CENTRAL LINE CDS, Pack Number CDS930092W ; 14) CENTRAL LINE CDS, Pack Number CDS930092X ; 15) C LINE INSERTION CDS, Pack Number CDS980379I ; 16) C LINE INSERTION CDS, Pack Number CDS980379J ; 17) AV FISTULA - SMH, Pack Number CDS980916L ; 18) AV FISTULA CDS, Pack Number CDS981513G ; 19) VASCULAR ACCESS CDS , Pack Number CDS981552F ; 20) VP SHUNT CDS, Pack Number CDS981740G ; 21) VP SHUNT CDS, Pack Number CDS981740I ; 22) PORT A CATH , Pack Number CDS982047Q ; 23) SHY VP SHUNT CDS, Pack Number CDS982389J; 24) MINI VASCULAR CDS QVH-LF, Pack Number CDS982524F ; 25) A-V FISTULA , Pack Number CDS982637K ; 26) A-V FISTULA , Pack Number CDS982637L ; 27) VASCULAR TRAUMA , Pack Number CDS982641K ; 28) AV FISTULA CDS, Pack Number CDS982660G ; 29) AV FISTULA CDS, Pack Number CDS982660I ; 30) PORT/TRACH INSERTION CDS-3, Pack Number CDS983004D ; 31) AV FISTULA/ACCESS , Pack Number CDS983060I ; 32) AV FISTULA/ACCESS , Pack Number CDS983060J ; 33) AV SHUNT CDS, Pack Number CDS983098B ; 34) AV SHUNT CDS, Pack Number CDS983098C ; 35) VASCULAR ACCESS CDS , Pack Number CDS983105C ; 36) VP SHUNT, Pack Number CDS983366K ; 37) VP SHUNT, Pack Number CDS983366L ; 38) AV FISTULA, Pack Number CDS983638G ; 39) AV FISTULA, Pack Number CDS983638I ; 40) AV FISTULA, Pack Number CDS983638J ; 41) BARIATRIC CDS , Pack Number CDS983657J ; 42) BARIATRIC CDS , Pack Number CDS983657K ; 43) BARIATRIC CDS , Pack Number CDS983883C ; 44) GROTH AV FISTULA CDS, Pack Number CDS984191P ; 45) GROTH AV FISTULA CDS, Pack Number CDS984191Q ; 46) GROTH AV FISTULA CDS, Pack Number CDS984191S ; 47) GROTH LASER VEIN CDS, Pack Number CDS984193Q ; 48) GROTH LASER VEIN, Pack Number CDS984193R; 49) SHY AV FISTULA CDS, Pack Number CDS984512G ; 50) AV FISTULA, Pack Number CDS985510G ; 51) THORACOSTOMY TRAY , Pack Number CHT2010; 52) TRAUMA CHEST TUBE SET , Pack Number CHT2015; 53) BARD MYPICC$ KIT, Pack Number CK000234A; 54) BARD MYPICC$ KIT, Pack Number CK000236A; 55) BARD MYPICC$ KIT, Pack Number CK000324 ; 56) BARD MYPICC$ KIT, Pack Number CK000325 ; 57) BARD MYPICC$ KIT, Pack Number CK000645A; 58) BARD MYPICC$ KIT, Pack Number CK000646A; 59) BARD MYPICC$ KIT, Pack Number CK000647A; 60) BARD MYPICC$ KIT, Pack Number CK000713 ; 61) BARD MYPICC$ KIT, Pack Number CK000714 ; 62) CENTRAL LINE TRAY , Pack Number CVI4705; 63) CVC INSERTION PACK, Pack Number CVI4720; 64) ****, Pack Number CVI4720B ; 65) KIT LINE INSERTION, Pack Number CVI4730; 66) KIT LINE INSERTION, Pack Number CVI4730A ; 67) VENOUS ACCESS TRAY, Pack Number CVI4830B ; 68) PORT INSERTION PACK , Pack Number CVI4870; 69) MVHS CVC LUMEN TRAY , Pack Number CVI4920; 70) NO CATHETER BUNDLE, Pack Number CVI4925A ; 71) UAMS PORT INSERTION KIT , Pack Number CVI5040; 72) CVL INSERTION PACK, Pack Number CVI5065; 73) CVL INSERTION PACK, Pack Number CVI5065H ; 74) HEMODIALYSIS TRAY , Pack Number DT8800 ; 75) ERCP KIT, Pack Number DYKE1006A; 76) PULMONARY KIT , Pack Number DYKE1870 ; 77) PULMONARY KIT, Pack Number DYKE1870H; 78) KIT SURG ONC INSERT CENT.VENOU, Pack Number DYKMBNDL43A; 79) ULTRASOUND PACK , Pack Number DYNDA1249A ; 80) CT SCAN-TC, Pack Number DYNDA1380A ; 81) CT SCAN-TC, Pack Number DYNDA1380AH; 82) UMBILICAL ARTERIAL/VENOUS KIT, Pack Number DYNDA2077; 83) BAL KIT , Pack Number DYNDA2137B ; 84) STERILE PRE OP PACK , Pack Number

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 18, 2024

    HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·June 4, 2025

    CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)

    FDA Enforcement
    Class II ·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025

    CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)

    FDA Enforcement
    Class II ·Ongoing·Kung Shin Plastics Co. Ltd.·March 12, 2025