AccessGUDID - DEVICE: PRAS Oral H2S Organisms Agar with Lead Acetate (OHO-C) (00810048900404)

GUDID

Device Identifier (DI) Information

Brand Name: PRAS Oral H2S Organisms Agar with Lead Acetate (OHO-C)
Version or Model: AS-6430
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS-6430
Company Name: ANAEROBE SYSTEMS

Primary DI Number: 00810048900404
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 021192653 *Terms of Use

Device Description: AS-6430 Oral H2S Organisms Agar with Lead Acetate (OHO-C) is intended for the identification of volatile sulfur compound, primarily hydrogen sulfide, producing bacteria found in clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 100 x 15 mm agar plates. Slightly turbid light yellow. 4 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:	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?
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	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: 97b2dcb9-b3ce-4914-a680-1119ce4be4b6
Public Version Date: May 11, 2020
Public Version Number: 1
DI Record Publish Date: May 01, 2020