Duns Number:812503712
Device Description: First Aid Kit containing Medical Devices Class I and Drugs OTC: Elastic Band, Biohazard First Aid Kit containing Medical Devices Class I and Drugs OTC: Elastic Band, Biohazard Bag, Antiseptic Wipes, Facemask with shield, Nitrile Gloves.
Catalog Number
-
Brand Name
Honeywell Safety Products USA, Inc.
Version/Model Number
019746-0032L
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
-
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
817f1310-e10f-44ce-9523-4f5edda760db
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 26, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |