MEDRAD Mark V Provis Foot Switch with Cable KMA 562-I

GUDID 00616258020808

ASSY, CABLE, FOOT SWITCH, UDI, BATCH (86024942)(25 ft.)

BAYER MEDICAL CARE INC.

Foot-switch, electrical Foot-switch, electrical
Primary Device ID00616258020808
NIH Device Record Key8eac4a3e-70fb-4ede-8a20-e09231b30eea
Commercial Distribution StatusIn Commercial Distribution
Brand NameMEDRAD Mark V Provis Foot Switch with Cable
Version Model NumberKMA 562-I
Catalog NumberKMA 562-I
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
GS100616258020808 [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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-05

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