AccessGUDID - DEVICE: NA (00816576020164)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: H07
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H07
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576020164
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: HTM AGAR (Haemophilus Test Medium) For disk diffusion sensitivity testing of Haemophilus spp.

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):	Yes
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?
58611	Haemophilus species antimicrobial susceptibility culture medium IVD	A supplemented culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on Haemophilus species isolated from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTY	Culture Media, For Isolation Of Pathogenic Neisseria

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 80cf73cd-5c23-4ee5-8edd-3a9ef0a9e455
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016