200mL Sterile Disposable Qwik-Fit Syringe & QFT 200-FLS-Q

GUDID 00616258010090

Envision, Vistron, MCT- 200 ml syringe with quick fill tube (ASSY,PKG,SYR,200ML W/QFT,ODYSSY,MC,JA2) (85232886)

BAYER MEDICAL CARE INC.

Angiographic syringe
Primary Device ID00616258010090
NIH Device Record Keye0082b8e-ef7d-4156-a50c-15d3ca2d4876
Commercial Distribution StatusIn Commercial Distribution
Brand Name200mL Sterile Disposable Qwik-Fit Syringe & QFT
Version Model Number200-FLS-Q
Catalog Number200-FLS-Q
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
GS100616258010090 [Primary]
GS140616258010098 [Package]
Package: [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTInjector And Syringe, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-28
Device Publish Date2019-05-20

On-Brand Devices [200mL Sterile Disposable Qwik-Fit Syringe & QFT ]

10616258007523Envision, Vistron, MCT- 200 ml syringe with quick fill tube (CT - 200ML ENV/VIST SYRINGE KIT W/Q
10616258007240"Envision, Vistron, MCT- 200 ml syringe with quick fill tube (ASSY,PKG,SYR,200ML W/QFT,ODYSSY,MC
00616258005492Envision, Vistron, MCT- 200 ml syringe with quick fill tube (CT - 200ML ENV/VIST SYRINGE KIT W/Q
00616258010090Envision, Vistron, MCT- 200 ml syringe with quick fill tube (ASSY,PKG,SYR,200ML W/QFT,ODYSSY,MC,

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