MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector SIT 96V

GUDID 10616258007387

Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a female-to-female adaptor) for pre-filled syringes (SET,PKG,INTEG T/CV,MRI SIT 96V,RAD,MC,LA) (60728931)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing
Primary Device ID10616258007387
NIH Device Record Key195484a8-e61c-4016-a74a-af236ccc1a5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameMRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector
Version Model NumberSIT 96V
Catalog NumberSIT 96V
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 Kitfalse
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 Perscriptionfalse
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
GS100616258007380 [Primary]
GS110616258007387 [Package]
Contains: 00616258007380
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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector]

10616258007813Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a
10616258007387Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a
10616258007295Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a
10616258005529Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a
40616258010005Spectris MR Kit with Integral "T" (96" low pressure connector tubing, one way check valve and a
40616258021834ASSY,TUBE SET,SPECTRIS,96”,MC,WLD (86653516)
40616258021131SET,PKG,SIT96V,HEREDIA,RAD,MC,JA2 (86105489)
40616258021124SET,PKG,SIT96V,HEREDIA,RAD,MC,CH (86105497)
00616258021119SET,PKG,SIT96V,HEREDIA,RAD,MC,LA (86105500)
40616258021100SET,PKG,INTEG T/CV,SIT96V,HEREDIA,RAD,MC (86105438)

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