AccessGUDID - DEVICE: N/A (00819398026390)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: Z81
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z81
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398026390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Bovine Serum Albumin 0.2%, 3ml each, for enhanced growth of mycobacteria; optically clear, shatter resistant, polycarbonate tube, 20 per kit Used for the preparation of specimens for AFB culture. A growth stimulant for Mycobacterium tuberculosis.

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?
62160	Culture medium nutrient supplement IVD	A formulation of non-selective supplements containing nutrients e.g., (amino acids, sugars, minerals) or other additives (e.g., serum, haemoglobin) intend to enrich a culture medium to sustain and/or enhance the growth or isolation of a specific target microbial species from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSK	Supplement, Culture Media

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 583e349c-2591-45cb-a48e-f25c1b4da189
Public Version Date: June 24, 2020
Public Version Number: 1
DI Record Publish Date: June 16, 2020