AnaeroGRO AG25H

GUDID 00819398026321

Anaerobic Transport Medium, 15x103mm Tube with Hungate Septum Cap and No Swabs, 7ml. Hardy Diagnostics AnaeroGRO™ Anaerobic Transport Medium is recommended for use in maintaining the viability of obligate anaerobic microorganisms, as well as aerobic and facultatively anaerobic bacteria, during transport. Starswab™ Anaerobic Transport Systems are enclosed, self-contained, ready-to-use, sterile surgery packs, available with or without swabs, for maintaining anaerobic transport of clinical specimens.

HARDY DIAGNOSTICS

Anaerobic transport medium IVD Anaerobic transport medium IVD Anaerobic transport medium IVD Anaerobic transport medium IVD
Primary Device ID00819398026321
NIH Device Record Key853043d4-d633-4911-b584-b9f512064f51
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnaeroGRO
Version Model NumberAG25H
Catalog NumberAG25H
Company DUNS039981550
Company NameHARDY DIAGNOSTICS
Device Count20
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com
Phone800-266-2222
Emailtechservice@hardydiagnostics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100819398026321 [Unit of Use]
GS100819398026321 [Unit of Use]
GS100819398026321 [Unit of Use]
GS100819398026321 [Unit of Use]
GS100819398026338 [Primary]
GS100819398026338 [Primary]
GS100819398026338 [Primary]
GS100819398026338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSLCulture Media, Anaerobic Transport
JSLCulture Media, Anaerobic Transport
JSLCulture Media, Anaerobic Transport
JSLCulture Media, Anaerobic Transport

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

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00816576024445DuoPak A, BRU with Hemin and Vitamin K, Monoplate; BBE/LKV, Biplate. Hardy Diagnostics AnaeroGR
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