Duns Number:039612668
Device Description: "(1) ABSORBENT COMPRESS(10) ANTIBIOTIC OINTMENT(10) ANTISEPTIC TOWELETTE(6) BURN CREAM(5) "(1) ABSORBENT COMPRESS(10) ANTIBIOTIC OINTMENT(10) ANTISEPTIC TOWELETTE(6) BURN CREAM(5) FABRIC FINGERTIP BANDAGE(4) FABRIC KNUCKLE BANDAGE(1) FIRST AID FACTS GUIDE(1) FIRST AID TAPE(1) PLASTIC TWEEZERS(4) GAUZE PAD(1) GAUZE ROLL(1) INSTANT ICE PACK(2) NITRILE GLOVE(16) PLASTIC BANDAGE(1) SCISSORS(1) TRIANGULAR BANDAGE"
Catalog Number
H-1292
Brand Name
Uline First Aid Kit - 10 Person
Version/Model Number
H-1292
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFQ
Product Code Name
Gauze/Sponge, Internal
Public Device Record Key
1e0c9260-eb9e-45a7-82f9-5875f7a0b0b5
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
December 20, 2018
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 2 |