Duns Number:006961700
Device Description: All-purpose First Aid Kit, 140 assorted first aid items, includes one carrying case: 2 - A All-purpose First Aid Kit, 140 assorted first aid items, includes one carrying case: 2 - Antibiotic Ointments 0.03 OZ (0.9 g); 2 - Non-Sterile, Single-Use Vinyl Exam Gloves; 3 - Hand Cleansing Wipes 4 3/4 IN x 7 3/4 IN (12 cm x 19.6 cm); 1 - Paper Tape 1/2 IN x 5 YD (1.2 cm x 4.5 m); 6 - Sterile Pads 2 IN x 2 IN (5 cm x 5 cm); 2 - Nonstick Pads 2 IN x 3 IN (5 cm x 7.6 cm); 15 - Fabric Bandages 5/8 IN x 2 1/4 IN (1.5 cm x 5.7 cm); 10 - Fabric Bandages 3/4 IN x 3 IN (1.9 cm x 7.6 cm); 5 - Fabric Bandages 1 IN x 3 IN (2.5 cm x 7.6 cm); 10 - Butterfly Closures 1 3/4 IN x 3/8 IN (4.4 cm x .95 cm); 14 - Sheer Bandages 7/8 IN DIA (2.2 cm); 34 - Sheer Bandages 5/8 IN x 2 1/4 IN (1.5 cm x 5.7 cm); 30 - Sheer Bandages 3/4 IN x 3 IN (1.9 cm x 7.6 cm); 2 - Sheer Bandages 2 1/4 IN x 3 IN (5.7 cm x 7.6 cm); 1 - Instant Cold Pack; 1 - Set of Tweezers; 1 - First Aid Guide.
Catalog Number
-
Brand Name
Up&Up
Version/Model Number
245070686
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
b7a55528-8eff-4116-a6d9-8bf2d59d7b56
Public Version Date
February 03, 2020
Public Version Number
1
DI Record Publish Date
January 24, 2020
Package DI Number
10017276229377
Quantity per Package
24
Contains DI Package
00017276229370
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 |