Duns Number:805169331
Device Description: Combo Pack, Package contains: 1 Rolled Gauze 2 In. x 2.5 Yds. (50 mm x 2.28 m), 1 Waterpro Combo Pack, Package contains: 1 Rolled Gauze 2 In. x 2.5 Yds. (50 mm x 2.28 m), 1 Waterproof Tape 1/2 In. x 5 Yds. (12 mm x 4.5 m)
Catalog Number
-
Brand Name
CVP Health
Version/Model Number
761706163153
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"
Yes
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
OHO
Product Code Name
First Aid Kit Without Drug
Public Device Record Key
eb1c7ae6-7147-4cb4-9fb3-69a41ade86da
Public Version Date
October 05, 2020
Public Version Number
1
DI Record Publish Date
September 27, 2020
Package DI Number
10761706163150
Quantity per Package
72
Contains DI Package
00761706163153
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 | 1 |