Duns Number:039981550
Device Description: Alkaline Peptone Water, 8mL, 16x125mm tube, 20 tubes/boxAn enrichment medium for the culti Alkaline Peptone Water, 8mL, 16x125mm tube, 20 tubes/boxAn enrichment medium for the cultivation of Vibrio spp. from feces and other materials.
Catalog Number
K03
Brand Name
N/A
Version/Model Number
K03
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
KZI
Product Code Name
Culture Media, Enriched
Public Device Record Key
97bb68c5-09e8-4bb4-b76d-fdc3e24a9418
Public Version Date
June 09, 2020
Public Version Number
1
DI Record Publish Date
June 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 | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |