Duns Number:021192653
Device Description: AS-919 Anaerobic Tissue Transport Medium (ATTM) is a mineral salt based semi-solid media w AS-919 Anaerobic Tissue Transport Medium (ATTM) 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). 8 mL fill volume. 28 x 57 screw top vial. Transparent colorless semi-solid. 5 tubes per pack.
Catalog Number
AS-919
Brand Name
PRAS Anaerobic Tissue Transport Medium (ATTM)
Version/Model Number
AS-919
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSL
Product Code Name
Culture Media, Anaerobic Transport
Public Device Record Key
fffbebc1-eec4-4a37-b4b1-61eab1ca9632
Public Version Date
May 11, 2020
Public Version Number
1
DI Record Publish Date
May 01, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 148 |