CBL,HANDSWITCH,5',HEAD,MCT2.0,UDI,BATCH EHS 700 05

GUDID 00616258010403

CBL,HANDSWITCH,5',HEAD,MCT2.0,UDI,BATCH (85591304)

BAYER MEDICAL CARE INC.

CT contrast medium injection system, line-powered, mobile
Primary Device ID00616258010403
NIH Device Record Key9c2d9079-607e-4b44-880a-b6bd84cddf71
Commercial Distribution StatusIn Commercial Distribution
Brand NameCBL,HANDSWITCH,5',HEAD,MCT2.0,UDI,BATCH
Version Model NumberEHS 700 05
Catalog NumberEHS 700 05
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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
GS100616258010403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXTInjector And Syringe, Angiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-22