Duns Number:051957769
Device Description: All-Purpose First Aid Kit, 140 items: 36 – Antibacterial Sheer Bandages 3/4 IN x 3 IN (19 All-Purpose First Aid Kit, 140 items: 36 – Antibacterial Sheer Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 26 – Antibacterial Sheer Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 12 - Antibacterial Waterproof Bandages 3/4 IN x 2 IN (19 mm x 50 mm); 4 - Antibacterial Fabric Bandages 2 IN x 4 IN (50 mm x 101 mm); 5 – Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm); 3 – Fabric Knuckle Bandages 1 1/2 IN x 3 IN (38 mm x 76 mm); 12 – Alcohol Prep Pads 1 3/16 IN x 2 5/16 IN (30 mm x 58 mm); 6 – Antiseptic Wipes 4 3/4 IN x 7 3/4 IN (120 mm x 196 mm); 4 – Acetaminophen Tablets (2 per packet); 4 – Allergy Caplets (1 per packet); 3 – Triple Antibiotic Ointments 1/32 OZ (0.9 g); 1 – First Aid & Burn Cream 1/32 OZ (0.9 g); 4 - Cotton Tipped Applicator 3 IN (76 mm); 2 – Nitrile Exam Gloves; 2 – Wooden Finger Splints; 1 – Paper Tape 1 IN x 5 YD (25 mm x 4.5 m); 1 –Metal Tweezers;1 –Single Use Instant Cold Pack; 1 – First Aid Guide; 6 – Gauze Pads 2 IN x 2 IN (50 mm x 50 mm); 3 – Non-stick Pads 2 IN x 3 IN (50 mm x 76 mm); 2 – Gauze Pads 4 IN x 4 IN (101 mm x 101 mm); 1 - Carrying Case
Catalog Number
-
Brand Name
Equate
Version/Model Number
681131228312
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
5616d6bf-cd9c-45a5-9b51-77599184613a
Public Version Date
December 30, 2019
Public Version Number
1
DI Record Publish Date
December 20, 2019
Package DI Number
30681131228313
Quantity per Package
6
Contains DI Package
00681131228312
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 |