AccessGUDID - DEVICE: AnaeroGRO (00819398026338)

GUDID

Device Identifier (DI) Information

Brand Name: AnaeroGRO
Version or Model: AG25H
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AG25H
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398026338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33355	Anaerobic transport medium IVD	A vessel containing transport medium intended to be used for the preservation and transport of anaerobic microorganisms from a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JSL	Culture Media, Anaerobic Transport

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K944847	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 853043d4-d633-4911-b584-b9f512064f51
Public Version Date: May 21, 2020
Public Version Number: 1
DI Record Publish Date: May 13, 2020