Duns Number:001180207
Device Description: Consumer First Aid Kit, containing first aid items to help treat minor injuries
Catalog Number
FAO-181
Brand Name
First Aid Only
Version/Model Number
FAO-181
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
September 30, 2023
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)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRR
Product Code Name
First Aid Kit With Drug
Public Device Record Key
2e1e60b0-1285-4f46-9586-64eaa7d6be75
Public Version Date
April 15, 2021
Public Version Number
2
DI Record Publish Date
October 02, 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 | 303 |