Disposable MRI Kit with Check Valve SQK 65VA

GUDID 40616258021568

SPECTRIS,KIT,SYR,MRI,65ML,MC,WLD (86594188)

BAYER MEDICAL CARE INC.

Angiographic syringe
Primary Device ID40616258021568
NIH Device Record Key9e65dac9-dce5-4874-b030-02ea480005e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable MRI Kit with Check Valve
Version Model NumberSQK 65VA
Catalog NumberSQK 65VA
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100616258021560 [Primary]
GS140616258021568 [Package]
Contains: 00616258021560
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-04
Device Publish Date2019-10-25

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40616258010036Spectris MR KIT,SYR/SPIKE/T,65ML FLS,MRI,BURRON and FFA 50 (KIT,SYR/SPIKE/T,65ML FLS,MRI,BUR, MC
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40616258021568SPECTRIS,KIT,SYR,MRI,65ML,MC,WLD (86594188)
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