Duns Number:051957769
Device Description: Blister Care First Aid Kit, 10 pieces: 4 - Alcohol Prep Pads 1 3/16 IN x 2 5/16 IN (30 mm Blister Care First Aid Kit, 10 pieces: 4 - Alcohol Prep Pads 1 3/16 IN x 2 5/16 IN (30 mm x 58 mm); 1 - Triple Antibiotic Ointments 1/32 OZ (0.9 g); 2 - Toe Blister Cushions 0.67 IN x 2.0 IN (17 mm x 51 mm); 2 - Finger Blister Cushions 0.78 IN x 2.36 IN (20 mm x 60 mm); 1 - Carrying Case
Catalog Number
-
Brand Name
Ozark Trail Outdoor Equipment
Version/Model Number
017276235906
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 25, 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
ab17a2e2-d17a-4f72-bcc1-07208cde08cd
Public Version Date
August 16, 2021
Public Version Number
2
DI Record Publish Date
December 16, 2019
Package DI Number
20017276235900
Quantity per Package
12
Contains DI Package
00017276235906
Package Discontinue Date
January 25, 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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |