AccessGUDID - DEVICE: PRAS Peptone Yeast Extract Broth w/ Glucose & Gelatin (PYG GELATIN) (00810048901081)

GUDID

Device Identifier (DI) Information

Brand Name: PRAS Peptone Yeast Extract Broth w/ Glucose & Gelatin (PYG GELATIN)
Version or Model: AS-860
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS-860
Company Name: ANAEROBE SYSTEMS

Primary DI Number: 00810048901081
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 021192653 *Terms of Use

Device Description: AS-860 Peptone Yeast Extract Broth with Glucose and Gelatin (PYG GELATIN) is an enriched non-selective broth media used in the growth and partial identification of anaerobic bacteria based on their specific biochemical features. Pre-reduced anaerobically sterilized (PRAS). 5 mL fill volume. 16 x 100 mm hungate-capped tubes. Transparent golden yellow liquid. 10 tubes per pack.

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?
62082	Nutrient gelatin culture medium IVD	A non-selective culture medium containing gelatin intended to be used to detect gelatin liquefaction by a gelatinase-producing microorganism and for the general growth and isolation of microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JSH	Culture Media, Non-Selective And Differential

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 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6f53a778-c45b-41ff-8ad4-157f990470cf
Public Version Date: May 11, 2020
Public Version Number: 1
DI Record Publish Date: May 01, 2020