AccessGUDID - DEVICE: PRAS BRU PEA BBE/LKV Convenience Pack (00810048901326)

GUDID

Device Identifier (DI) Information

Brand Name: PRAS BRU PEA BBE/LKV Convenience Pack
Version or Model: AS-323
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS-323
Company Name: ANAEROBE SYSTEMS

Primary DI Number: 00810048901326
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021192653 *Terms of Use

Device Description: AS-323 BRU, PEA, and BBE/LKV Convenience Pack - Includes 1 Brucella Blood Agar (BRU), 1 Phenylethyl Alcohol Blood Agar (PEA), and 1 Bacteroides Bile Esculin Agar (BBE)/Laked Brucella Blood Agar with Kanamycin and Vancomycin (LKV) Biplate. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plate. BRU is opaque burgundy red. PEA is opaque red. BBE is transparent yellow/green. LKV is transparent red. 3 plates 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:	Yes
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?
62106	Multiple formulation agar culture medium IVD	A combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZI	Culture Media, Enriched
JSH	Culture Media, Non-Selective And Differential
JSJ	Culture Media, Selective And Non-Differential
JSI	Culture Media, 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: 8ca7cc3d-8af0-4e38-abf4-c26fee81a6c5
Public Version Date: May 11, 2020
Public Version Number: 1
DI Record Publish Date: May 01, 2020