Duns Number:062312574
Device Description: 3-Step Kit for Medium Wounds, 13 pieces: 2 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 2 - T 3-Step Kit for Medium Wounds, 13 pieces: 2 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 2 - Triple Antibiotic Ointment 1/32 OZ (0.9 g); 2 - Non-stick Pads 2 IN x 3 IN (50 mm x 76 mm); 2 - Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm); 1 - Rolled Gauze 2 IN x 2 YDS (50 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
364086
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
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
b3cf2680-bacf-4529-a67b-18d441fb4db5
Public Version Date
December 05, 2019
Public Version Number
2
DI Record Publish Date
May 24, 2019
Package DI Number
20050428614048
Quantity per Package
18
Contains DI Package
00050428614044
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |