GUDID 00848838018855

REMEL, INC.

Mueller-Hinton broth antimicrobial susceptibility culture medium IVD
Primary Device ID00848838018855
NIH Device Record Key505e537f-a69b-4f14-861b-708f0963e471
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCP114-10
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
GS100848838018855 [Primary]
GS100848838099670 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWYManual Antimicrobial Susceptibility Test Systems

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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