Duns Number:051957769
Device Description: All-Purpose First Aid Kit, 205 items: 40 - Antibacterial Sheer Bandages 7/8 IN (22 mm); 30 All-Purpose First Aid Kit, 205 items: 40 - Antibacterial Sheer Bandages 7/8 IN (22 mm); 30 - Antibacterial Sheer Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 30 - Antibacterial Fabric Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 20 - Antibacterial Fabric Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 14 - Butterfly Closures 1 3/4 IN x 3/8 IN (44 mm x 9 mm); 20 – Alcohol Prep Pads 1 3/16 IN x 2 5/16 IN (30 mm x 58 mm); 8 - Acetaminophen (2 tablets per packet); 5 - Hydrocortisone Cream 1/32 OZ (0.9 g); 4 – Diphen Allergy Caplets (1 caplet per packet); 3 - 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 - Topical Cooling Gel 1/8 OZ (3.5 g); 1 – First Aid & Burn Cream 1/32 OZ (0.9 g); 1 - Sunscreen Lotion SPF 30 1/8 OZ (3.5 g); 4 – Wooden Finger Splints; 2 - Cotton Tipped Applicators 3 IN (76 mm) 2 per packet; 2 - Nitrile Gloves; 1 - Single use instant Cold Pack; 1 - Pair of Tweezers; 1 - Paper Tape 1/2 IN x 5 YDS (12.7 mm x 4.5 m); 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); 1 - Gauze Pad 4 IN x 4 IN (101 mm x 101 mm); 1 - Hydrogel Burn Pad 1.96 IN x 2.96 IN (49 mm x 74 mm); 1 - Rolled Gauze 2 IN x 2.5 YDS (50 mm x 2.28 m); 1 - Carrying case
Catalog Number
-
Brand Name
Ozark Trail Outdoor Equipment
Version/Model Number
017276235869
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 26, 2021
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
7ddfdbbf-7c70-4220-b57a-6ebfa3679059
Public Version Date
August 19, 2021
Public Version Number
2
DI Record Publish Date
December 09, 2019
Package DI Number
20017276235863
Quantity per Package
2
Contains DI Package
00017276235869
Package Discontinue Date
January 26, 2021
Package Status
Not 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 |