Duns Number:985523874
Device Description: Fecal Diagnostic Kit Refill, Disposable, Non-sterile
Catalog Number
-
Brand Name
AmerisourceBergen
Version/Model Number
11504
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NNK
Product Code Name
Container, Specimen Mailer And Storage, Non-Sterile
Public Device Record Key
9c1fcf6b-e1f2-4f5f-8454-494cba70aec3
Public Version Date
November 01, 2021
Public Version Number
1
DI Record Publish Date
October 22, 2021
Package DI Number
60368001115041
Quantity per Package
8
Contains DI Package
00368001115049
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |