Duns Number:006961700
Device Description: Travel First Aid Kit, 70 assorted first aid items, including one carrying case: 5 - Fabric Travel First Aid Kit, 70 assorted first aid items, including one carrying case: 5 - Fabric Bandages 1 IN x 3 IN (2.5 cm x 7.6 cm); 10 - Fabric Bandages 3/4 IN x 3 IN (1.9 cm x 7.6 cm); 15 - Fabric Bandages 5/8 IN x 2 1/4 IN (1.5 cm x 5.7 cm); 6 - Hand Cleansing Wipes 4 3/4 IN x 7 3/4 IN (12 cm x 19.6 cm); 4 - Antibiotic Ointments 0.03 OZ (0.9 g); 8 - Sterile Pads 2 IN x 2 IN (5 cm x 5 cm); 21 - Sheer Bandages 3/4 IN x 3 IN (1.9 cm x 7.6 cm)
Catalog Number
-
Brand Name
Up&Up
Version/Model Number
245070679
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
cc45dc04-8c14-44de-84a5-b69c9b0c12ae
Public Version Date
February 03, 2020
Public Version Number
1
DI Record Publish Date
January 24, 2020
Package DI Number
10017276229360
Quantity per Package
36
Contains DI Package
00017276229363
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |
| U | Unclassified | 12 |