Saline Syringe & Tubing for MR Injector System SSQK 115

GUDID 00616258007021

Saline Syringe and Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC,JA) (84192945)

BAYER MEDICAL CARE INC.

Angiographic syringe
Primary Device ID00616258007021
NIH Device Record Key720f5bdd-a121-40b1-8031-a4b3c7b572ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameSaline Syringe & Tubing for MR Injector System
Version Model NumberSSQK 115
Catalog NumberSSQK 115
Company DUNS058716649
Company NameBAYER MEDICAL CARE INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-7231
Emailricustomercomplaints@bayer.com
Phone+1(800)633-7231
Emailricustomercomplaints@bayer.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100616258007021 [Primary]

FDA Product Code

DXTInjector And Syringe, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [Saline Syringe & Tubing for MR Injector System]

40616258010029Saline Syringe and Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC,JA2) (852
00616258007021Saline Syringe and Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC,JA) (8419
00616258005461Saline Syringe & Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC) (60728605)
40616258021872MR,KIT,SYR,MRI,115ML,96”,MC,WLD (86645556)
40616258024521MR,KIT,SYR,MRI,115ML,96",MC,CORE (87622568)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.