Duns Number:533284357
Device Description: Affinity is a device used to clean a tissue (skin) by a tiny jets of sterile fluid. The d Affinity is a device used to clean a tissue (skin) by a tiny jets of sterile fluid. The device consists of tip with the nozzles arragement,tubing to connect to a container of sterile fluid, and a means ofpropelling the fluid through the nozzles, such as an electric roller pump.
Catalog Number
-
Brand Name
Disposable tips box
Version/Model Number
FG00006
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
-
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
FQH
Product Code Name
Lavage, Jet
Public Device Record Key
2dfafbd1-2c37-4a91-abd9-56cda88af0a7
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
July 07, 2017
Package DI Number
17290017249022
Quantity per Package
10
Contains DI Package
07290017249018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |