Duns Number:047741335
Device Description: Wound Care Kit, 25 items: 8 - Gauze Pads 4 IN x 4 IN (101 mm x 101 mm), 4 - Gauze Pads 2 I Wound Care Kit, 25 items: 8 - Gauze Pads 4 IN x 4 IN (101 mm x 101 mm), 4 - Gauze Pads 2 IN x 2 IN (50 mm x 50 mm), 4 - Non-Stick Pads 2 IN x 3 IN (50 mm x 76 mm), 4 - Non-Stick Pads 3 IN x 4 IN (76 mm x 101 mm), 4 - Rolled Gauze 4 IN x 2.5 YDS (101 mm x 2.28 m), 1 - Paper Tape 1 IN x 10 YDS (25 mm x 9.14 m)
Catalog Number
-
Brand Name
Discount Drug Mart Food Fair
Version/Model Number
093351031878
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
3a7cd988-53ce-445b-aa22-b70356880886
Public Version Date
September 15, 2020
Public Version Number
1
DI Record Publish Date
September 07, 2020
Package DI Number
20093351031872
Quantity per Package
36
Contains DI Package
00093351031878
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |