GUDID 00848838001932

REMEL, INC.

Haemophilus species antimicrobial susceptibility culture medium IVD
Primary Device ID00848838001932
NIH Device Record Keya3756816-07db-4ed9-8834-b93cac72ad70
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberR01503
Company DUNS065769564
Company NameREMEL, INC.
Device Count10
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8002556730
EmailITechnicalSupport@remel.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848838001932 [Primary]
GS100848838099465 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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 Date2016-09-24

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