Duns Number:152793493
Device Description: Wound Care Kit, 40 items: 10 - Gauze Pad 4 IN x 4 IN (101 mm x 101 mm); 10 - Antiseptic Wi Wound Care Kit, 40 items: 10 - Gauze Pad 4 IN x 4 IN (101 mm x 101 mm); 10 - Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 12 - Non-Stick Pads 3 IN x 4 IN (76 mm x 101 mm); 4 - Transparent Dressings 2.36 IN x 2.75 IN (59 mm x 69 mm); 3 - 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
ALL-HEALTH Wound Care Products
Version/Model Number
017276234466
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
6ac6fff9-9190-48ef-8b37-0200ce51a360
Public Version Date
December 05, 2019
Public Version Number
2
DI Record Publish Date
October 30, 2019
Package DI Number
20017276234460
Quantity per Package
36
Contains DI Package
00017276234466
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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |