48 results
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47ms
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Sources: EU EUDAMED, US FDA
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CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 151-143XLP, Contents; Wall Charger, Instructions, +B101150143XLP0/$$7A23456/16D000112010, Manufactured By: CME America LLC, 14988 W. 6th Ave., Suite 830, Golden. CO 80401, USA, SM-0706 Rev 00 External Charger INPUT ; AC 100-240V, 50-60Hz; 10W, 0.3A max., OUTPUT: DC 8.4V, 300mA/DC 9V, 800mA, CME America, LLC , Label ID: SM-0718, Rev. 00 Label, Wall Mount Charger, Pump Service: Use with CME Pumps & Accessories ONLY. Refer Servicing to Qualified Personnel., LABEL I.D. : SM-0756 REV 00
FDA Enforcement
Class II
·Terminated·CME America LLC·November 4, 2020
BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously.
FDA Enforcement
Class I
·Terminated·CME America, LLC·March 18, 2020
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
FDA Enforcement
Class I
·Terminated·CME America, LLC·March 25, 2020
BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
FDA Enforcement
Class II
·Terminated·CME America, LLC·February 25, 2015
BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care environments.
FDA Enforcement
Class II
·Terminated·CME America, LLC·May 13, 2020
BodyGuard Microset with Filter, REF: A120-160XSFE
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-003XS2YV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-112XSFK
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
Standard BodySet with Needleless Connectors, REF: A120-125XS
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-160GCFA
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Needleless Y Site Microbore Set, REF: A120-160CYNVK
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A120-161XYB
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Sets, REF: A120-160C2YRV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Sets, REF: A120-161C
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset, REF: A100-163XESV
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard Microset with Needleless Adaptor, REF: A120-003XSNY
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard BodySet, REF: A120-160SAS
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Set, REF: A120-160C
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
BodyGuard set with Female Luer, REF: A120-003XSN
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020
CMExpress Microbore Set, REF: A120-161CYF
FDA Enforcement
Class I
·Terminated·CME America, LLC·July 22, 2020