Duns Number:152793493
Device Description: First Aid Kit 351 pieces: 39 Alcohol Prep Pads 1 3/16 IN X 2 5/16 IN (30 MM X 58 MM); 12 A First Aid Kit 351 pieces: 39 Alcohol Prep Pads 1 3/16 IN X 2 5/16 IN (30 MM X 58 MM); 12 Antiseptic Wipes 4 3/4 IN X 7 3/4 IN (120 MM X 196 MM); 10 Hand Sanitizers 1/32 OZ (0.9 G); 6 Hand Cleansing Wipes 4 3/4 IN X 7 3/4 IN (120 MM X 196 MM); 1 Eye Wash 1 FL OZ (30 ML); 14 Triple Antibiotic Ointments 1/32 OZ (0.9 G); 10 Topical Cooling Gel 1/8 OZ (3.5 G); 1 Acetaminophen (Non-aspirin) packet; 1 Diphen Allergy Caplet; 10 Hydrocortisone Cream 1/32 OZ (0.9 G); 2 Ibuprofen Packets; 1 Burn Dressing 4 IN X 4 IN (101 MM X 101 MM); 1 Instant Cold Pack 4 IN X 5 IN (101 MM X 125 MM); Sheer Bandages: 10- 3/4 IN X 3 IN (19 MM X 76 MM), 40- 1 IN X 3 IN (25 MM X 76 MM), 60- 3/8 IN X 1 1/2 IN (9.5 MM X 38 MM); 35 Butterfly Closures 1 3/4 IN X 3/8 IN (44 MM X 9.5 MM); 8 Gauze Pads 2 IN x 2 IN (50 MM x 50 MM); 4 Gauze Pads 4 IN x 4 IN (101 MM x 101 MM); 4 Transparent Dressings 2 3/8 IN X 4 IN (60 MM X 101 MM); 2 Trauma Pads 5 in x 9 in (127 MM x 228 MM); 2 Eye Cover Pads 2.25 IN x 3.03 IN (57 MM x 77 MM); 1 Rolled Gauze 4 IN x 2 1/2 YDS (101 MM x 2.2 M); 7 Wooden Finger Splints; 4 Nitrile Exam Gloves; 1 CPR Breathing Barrier; 1 Paper Tape1 IN X 5 YDS (25 MM X 4.5 M); 1 Triangular Sling 40 IN X 40 IN X 56 IN (101 CM X 101 CM X 142 CM); 1 Metal Scissors; 1 Metal Tweezers; 1 First Aid Guide
Catalog Number
B07CGFT1FF
Brand Name
Care Science
Version/Model Number
00017276237771
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
fea4e769-7a53-4ec9-88b9-eec1ae523d7a
Public Version Date
May 26, 2021
Public Version Number
1
DI Record Publish Date
May 18, 2021
Package DI Number
20017276237775
Quantity per Package
3
Contains DI Package
00017276237771
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 | 48 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |
U | Unclassified | 1 |