Duns Number:006959555
Device Description: Wound Care Kit, 25 items, assorted sizes: 8 - Gauze Pads 4 IN x 4 IN (101 mm x 101 mm); 4 Wound Care Kit, 25 items, assorted sizes: 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 YD (25 mm x 9.14 m).
Catalog Number
4434358
Brand Name
meijer
Version/Model Number
708820393561
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
467f0603-a19b-488d-82c0-c52d15f31cf3
Public Version Date
December 20, 2019
Public Version Number
2
DI Record Publish Date
July 31, 2019
Package DI Number
10708820393568
Quantity per Package
36
Contains DI Package
00708820393561
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |