Duns Number:062312574
Device Description: 3-Step Kit for Large Wounds, 15 pieces: 2 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 3 - Tr 3-Step Kit for Large Wounds, 15 pieces: 2 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 3 - Triple Antibiotic Ointment 1/32 OZ (0.9 g); 2 - Non-stick Pads 3 IN x 4 IN (76 mm x 101 mm); 3 - Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm); 1 - Rolled Gauze 4 IN x 2 YDS (101 mm x 1.8 m); 4 Pre-cut Tape Strips 1 1/4 IN x 5 IN (31 mm x 127 mm)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
364080
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 30, 2021
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
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
6967872d-e8e1-4eec-abf8-c59afb8bd523
Public Version Date
August 03, 2022
Public Version Number
3
DI Record Publish Date
May 24, 2019
Package DI Number
20050428614185
Quantity per Package
18
Contains DI Package
00050428614181
Package Discontinue Date
December 30, 2021
Package Status
Not 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |