ADS Medical

GUDID 00811925030009

ADS Medical iFOB Test Kit, 30 Cassettes and 50 Collection Tubes per Box Kit with 50 Mailers

W.H.P.M. INC.

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Primary Device ID00811925030009
NIH Device Record Key6092b76d-3d39-4508-a9e9-afab9c9a4b99
Commercial Distribution StatusIn Commercial Distribution
Brand NameADS Medical
Version Model NumberT1-CK30-ADSM
Company DUNS602085672
Company NameW.H.P.M. INC.
Device Count30
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811925030009 [Primary]
GS100811925030016 [Unit of Use]

FDA Product Code

KHEReagent, Occult Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-30
Device Publish Date2018-03-29

On-Brand Devices [ADS Medical]

00811925030078ADS Medical iFOB Collection Tube, 50 Purple Cap Collection Tubes with Short Label per Box
00811925030061ADS Medical iFOB Collection Tube, 30 Purple Cap Collection Tubes with Short Label per Box
00811925030054ADS Medical iFOB Test, 50 Cassettes per Box
00811925030047ADS Medical iFOB Test, 30 Cassettes per Box
00811925030030ADS Medical iFOB Test Kit, 50 Cassettes and 50 Collection Tubes per Box Kit without Mailer
00811925030023ADS Medical iFOB Test Kit, 30 Cassettes and 30 Collection Tubes per Box Kit without Mailer
00811925030009ADS Medical iFOB Test Kit, 30 Cassettes and 50 Collection Tubes per Box Kit with 50 Mailers

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