AccessGUDID - DEVICE: NA (00816576020218)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: J101
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: J101
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00816576020218
Issuing Agency: GS1
Commercial Distribution End Date: June 17, 2020
Device Count: 10
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: CHOCOLATE with BAC / MTM BIPLT (Section I: Chocolate with Bacitracin; Section II: Modified Thayer Martin). For the selective isolation of fastidious bacteria.

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?
58610	Haemophillus species agar identification medium IVD	A selective and/or differential agar culture medium intended to be used for the identification of Haemophilus species in a clinical specimen using supplementary X, V and XV factors supplied by disc diffusion.	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: 10e4525e-851f-406c-b101-bc415a153e5c
Public Version Date: June 18, 2020
Public Version Number: 3
DI Record Publish Date: September 02, 2016