Duns Number:878070325
Device Description: Wounded Warrior PPE Kit-Small; Each Kit Includes Small Nitrile Exam Glove (2), 2 oz Scente Wounded Warrior PPE Kit-Small; Each Kit Includes Small Nitrile Exam Glove (2), 2 oz Scented Hand Sanitizer, Large Alcohol Prep Pad (4), and 3 Ply Mask.
Catalog Number
10-90702S
Brand Name
AFFLINK
Version/Model Number
10-90702S
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
PXC
Product Code Name
Personal Protection Kit
Public Device Record Key
b722417d-a94a-4871-a678-b6cd627cbac7
Public Version Date
July 12, 2021
Public Version Number
1
DI Record Publish Date
July 02, 2021
Package DI Number
10818634024876
Quantity per Package
30
Contains DI Package
00818634024879
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 72 |