Duns Number:051957769
Device Description: On-The-Go First Aid Kit, 85 items: 22 – Antibacterial Sheer Bandages 3/4 IN x 3 IN (19 mm On-The-Go First Aid Kit, 85 items: 22 – Antibacterial Sheer Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 24 – Antibacterial Sheer Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 10 – Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm); 3 - Antibacterial Fabric Bandages 2 IN x 4 IN (50 mm x 101 mm); 6 – Alcohol Prep Pads 1 3/16 IN x 2 5/16 IN (30 mm x 58 mm); 4 – Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 2 – Triple Antibiotic Ointments 1/32 OZ (0.9 g); 2 – Nitrile Exam Gloves; 2 – Wooden Finger Splints; 1 – Paper Tape 1/2 IN x 5 YD (12.7 mm x 4.5 m); 1 – Single Use Instant Cold Pack; 1 – First Aid Guide; 2 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 1 – Non-stick Pads 2 IN x 3 IN (50 mm x 76 mm); 1 – Gauze Pads 4 IN x 4 IN (101 mm x 101 mm); 2 - Cotton Tipped Applicators; 1 - Carrying Case
Catalog Number
-
Brand Name
Equate
Version/Model Number
681131228329
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
942be6eb-833c-4bf8-af6d-e37b5c2e01ec
Public Version Date
March 31, 2021
Public Version Number
2
DI Record Publish Date
April 30, 2020
Package DI Number
20681131228323
Quantity per Package
24
Contains DI Package
00681131228329
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. | 76 |