Duns Number:039612668
Device Description: "(4) ABSORBENT COMPRESS(25) ANTIBIOTIC OINTMENT(50) ANTISEPTIC TOWELETTES(25) BURN CREAM(2 "(4) ABSORBENT COMPRESS(25) ANTIBIOTIC OINTMENT(50) ANTISEPTIC TOWELETTES(25) BURN CREAM(2) BURN DRESSING(1) CPROTECTOR(8) EYE PAD WITH TAPE(1) FIRST AID FACTS GUIDE(2) FIRST AID TAPE(1) PLASTIC TWEEZERS(4) GAUZE PADS(2) GAUZE ROLL - 2"" X 6 YD.(1) GAUZE ROLL - 4"" X 6 YD.(10) HAND SANITIZER(2) INSTANT ICE PACK(4) NITRILE GLOVES(64) PLASTIC BANDAGES(1) SAM SPLINT(1) SCISSORS(1) SINGLE USE SALINE (1) TOURNIQUET(2) TRIANGULAR BANDAGE"
Catalog Number
H-6470
Brand Name
Uline ANSI Approved First Aid Kit - Class B, 50 Person
Version/Model Number
H-6470
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
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
a894da73-95ed-4912-9713-7e26b1c074df
Public Version Date
June 10, 2022
Public Version Number
10
DI Record Publish Date
January 18, 2019
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 |