Fisher Labcorp ES Take Home Pack 80

GUDID 00613647001066

FISHER SCIENTIFIC COMPANY L.L.C.

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Primary Device ID00613647001066
NIH Device Record Keye6159f04-07d0-4e35-8e0f-9ff8b729d0df
Commercial Distribution StatusIn Commercial Distribution
Brand NameFisher Labcorp ES Take Home Pack 80
Version Model Number551790
Company DUNS004321519
Company NameFISHER SCIENTIFIC COMPANY L.L.C.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com
Phone+018007667000
EmailRegulatory.Affairs@thermofisher.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100613647001066 [Primary]

FDA Product Code

KHEREAGENT, OCCULT BLOOD

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

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