Duns Number:011920774
Device Description: All-purpose, First Aid Kit, 140 items, Including One Carrying Case: 34- Sheer Antibacteria All-purpose, First Aid Kit, 140 items, Including One Carrying Case: 34- Sheer Antibacterial* Bandages 5/8 in. x 2 1/4 in. (1.5 cm x 5.7 cm), 30- Sheer Antibacterial* Bandages 3/4 in. x 3 in. (1.9 cm x 7.6 cm), 15- Fabric Antibacterial* Bandages 5/8 in. x 2 1/4 in. (1.5 cm x 5.7 cm), 14- Sheer Antibacterial* Bandages 7/8 in. (2.2 cm), 12- Butterfly Closures 1 3/4 in. x 3/8 in. (4.4 cm x .95 cm), 10- Fabric Antibacterial* Bandages 3/4 in. x 3 in. (1.9 cm x 7.6 cm), 5- Fabric Antibacterial* Bandages 1 in. x 3 in. (2.5 cm x 7.6 cm), 2- Sheer Antibacterial* Bandages 2 1/4 in. x 3 in. (5.7 cm x 7.6 cm), 1- Instant Cold Pack 5 in. x 6 in. (12.7 cm x 15.3 cm), 1- Paper Tape Roll 1/2 in. x 5 yd. (1.2 cm x 4.5 m), 4- Hand Cleansing Wipes 4 3/4 in. x 7 3/4 in. (12 cm x 19.6 cm), 2- Triple Antibiotic Ointment 1/32 oz. (0.9 g), 6- Gauze Pads, 2 in. x 2 in. (5 cm x 5 cm)2- Non-Stick** Pads, 2 in. x 3 in. (5 cm x 7.6 cm), 1- Carrying Case, 1- First Aid Guide
Catalog Number
-
Brand Name
Quality Choice
Version/Model Number
635515998537
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
ac4b5aa4-3252-41b6-965d-5385ca3d6e74
Public Version Date
August 17, 2021
Public Version Number
1
DI Record Publish Date
August 09, 2021
Package DI Number
10635515998534
Quantity per Package
24
Contains DI Package
00635515998537
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |