AccessGUDID - DEVICE: PRAS Anaerobic Dental Transport Medium (DTM) (00810048901265)

GUDID

Device Identifier (DI) Information

Brand Name: PRAS Anaerobic Dental Transport Medium (DTM)
Version or Model: AS-920
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS-920
Company Name: ANAEROBE SYSTEMS

Primary DI Number: 00810048901265
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 021192653 *Terms of Use

Device Description: AS-920 Anaerobic Dental Transport Medium (DTM) is a mineral salt based semi-solid media with reducing agents. Designed as a holding medium to maintain the viability of microorganisms, both anaerobic and aerobic, through collection, transportation, and shipment of clinical specimens. Pre-reduced anaerobically sterilized (PRAS). 5 mL fill volume. 19 x 40 mm hungate-capped tube. Transparent colorless semi-solid medium. 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?
33355	Anaerobic transport medium IVD	A vessel containing transport medium intended to be used for the preservation and transport of anaerobic microorganisms from a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JSL	Culture Media, Anaerobic Transport

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: da250b58-a863-4036-807e-9e9e912b422d
Public Version Date: May 11, 2020
Public Version Number: 1
DI Record Publish Date: May 01, 2020