Duns Number:051957769
Device Description: All-Purpose First Aid Kit, 250 items: BANDAGES: 65-Antibacterial Sheer Bandages 3/4 IN X 3 All-Purpose First Aid Kit, 250 items: BANDAGES: 65-Antibacterial Sheer Bandages 3/4 IN X 3 IN (1.9 cm x 7.6 cm); 50-Antibacterial Sheer Bandages 5/8 IN X 2 1/4 IN ( 1.6 cm X 5.7 cm ); 20-Antibacterial Sheer Bandages 1 IN X 3 IN ( 2.5 cm X 7.6 cm ); 10-Antibacterial Waterproof Bandages 3/4 IN X 3 IN ( 1.9 cm X 7.6 cm ); 10-Butterfly Closures; 2- Antibacterial Sheer Bandages 2 IN X 4 IN ( 5 cm X 10.1 cm ) TOPICALS & MEDICINES: 15-Alcohol Wipes; 12-Antiseptic Wipes; 10-Aspirin Tablets 2 per packet; 10-Non-Aspirin Tablets 2 per packet; 4-Allergy Caplets ( Diphen ) 1 per packet; 2-Antibiotic Ointments 0.03 oz ( 0.9 g ); 2-Burn Creams 0.03 oz ( 0.9 g ); 2-Sting Relief Wipes INSTRUMENTS: 10-Cotton-Tipped Applicators; 3-Safety Pins; 2-Wooden Finger Splints; 2-Nitrile Exam Glove; 2-Single-Use Instant Cold Packs;1-Plastic Tweezer; 1-Paper Tape; 1/2 IN X 2 1/2 YDS ( 1.3 cm X 2.3 m );1-First Guide WOUND DRESSINGS: 8-Sterile Gauze Pads 2 IN X 2 IN ( 5 cm X 5 cm ); 4-Sterile Gauze Pads 4 IN X 4 IN ( 10.1 cm X 10.1 cm ); 1-Sterile Trauma Pad 5 IN X 9 IN ( 12.7 cm X 22.8 cm )1-Carrying Case.
Catalog Number
-
Brand Name
Equate
Version/Model Number
681131349789
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
30479496-f447-4a98-96c2-84285707a01c
Public Version Date
June 02, 2020
Public Version Number
1
DI Record Publish Date
May 25, 2020
Package DI Number
10681131349786
Quantity per Package
2
Contains DI Package
00681131349789
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 |