CT TRI-PAK Sterile Disposable Syringe CTP-200-FLS

GUDID 40616258010104

ASSY,PKG,SYR,TRI-PAK,200ML,ODY,MC,JA2 (85231421)

BAYER MEDICAL CARE INC.

Angiographic syringe
Primary Device ID40616258010104
NIH Device Record Key30895280-0b5b-4410-9025-b03a7799c6df
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT TRI-PAK Sterile Disposable Syringe
Version Model NumberCTP-200-FLS
Catalog NumberCTP-200-FLS
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
GS100616258010106 [Primary]
GS140616258010104 [Package]
Contains: 00616258010106
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 [CT TRI-PAK Sterile Disposable Syringe ]

00616258007793Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (AS
00616258007366Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (AS
10616258007264"Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60"" Low Pressure Connector Tube) (
00616258005485Tri-Pak (Includes:125 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (CT
00616258005430Tri-Pak (Includes:200 ML Qwik-Fit Syringe, Quick Fill Tube, 60" Low Pressure Connector Tube) (CT
40616258010104ASSY,PKG,SYR,TRI-PAK,200ML,ODY,MC,JA2 (85231421)
40616258021964MULTI,KIT,SYR,CT,200ML,MC,WLD (86660237)
40616258024385MULTI,KIT,SYR,CT,200ML,MC,CORE (87622576)

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