Duns Number:152793493
Device Description: All-Purpose, First Aid Kit, 300 pieces: 75 Plastic Bandages - 3/4 IN X 3 IN (19 MM X 76 MM All-Purpose, First Aid Kit, 300 pieces: 75 Plastic Bandages - 3/4 IN X 3 IN (19 MM X 76 MM); 50 Plastic Bandages - 5/8 IN X 2 1/4 IN (15 MM X 57 MM); 30 Plastic Bandages - 1 IN X 3 IN (25 MM X 76 MM); 20 Fabric Bandages - 3/4 IN X 3 IN (19 MM X 76 MM); 10 Fabric Bandages - 1 IN X 3 IN (25 MM X 76 MM); 4 Butterfly Closures - 1 3/4 IN X 3/8 IN (44 MM X 9.5MM); 4 Fabric Fingertip Bandages - 1 3/4 IN X 2 IN (44 MM X 50 MM); 4 Fabric Knuckle Bandages - 1 1/2 IN X 3 IN (38 MM X 76 MM); 2 Fabric Bandages - 2 IN X 4 IN (50 MM X 101 MM); 2 Sheer Bandages - 2 1/4 IN X 3 IN (57 MM X 76 MM); 15 Hand Cleansing Wipes - 4 3/4 IN X 7 3/4 IN (120 MM X 196 MM); 14 Alcohol Prep Pads - 1 3/16 IN X 2 5/16 IN (30 MM X 58 MM); 10 Hydrocortisone Cream - 1/32 OZ (0.9 G); 10 Triple Antibiotic Ointment - 1/32 OZ (0.9 G); 4 Antiseptic Wipes - 4 3/4 IN X 7 3/4 IN (120 MM X 196 MM); 4 Ibuprofen - 2 Per Packet; 2 Acetaminophen (Non-Aspirin) -2 Per Packet; 2 Topical Cooling Gel-1/8 OZ(3.5G);1 Diphen Allergy Caplet - 1 Per Packet; 1 First Aid Burn Cream - 1/32 OZ (0.9 G); 2 Wooden Finger Splints; 2 Nitrile Gloves; 2 Paper Tape Rolls - 1/2 IN X 5 YDS (12.5 MM X 4.5 M); 1 Carrying Case; 1 First Aid Guide; 1 Instant Cold Pack; 1 Metal Scissors; 1 Metal Tweezers; 1 Triangular Sling - 40 IN X 40 IN X 56 IN (101 CM X 101 CM X 142 CM); 8 Blister Cushions - 0.67 IN X 2 IN (17 MM X 50 MM); 6 Gauze Pads - 2 IN X 2 IN (50 MM X 50 MM); 4 Gauze Pads - 3 IN X 3 IN (76 MM X 76 MM); 2 Gauze Pads - 4 IN X 4 IN (101 MM X 101 MM); 1 Burn Dressing - 4 IN X 4 IN (100 MM X 100 MM); 1 Eye Cover Pad - 2 1/4 IN X 3 IN (57 MM X 77 MM); 1 Rolled Gauze - 2 IN X 2 1/2 YDS (50 MM X 2.2 M); 1 Trauma Pad - 5 IN X 9 IN (127 MM X 228 MM)
Catalog Number
B07VGYDFPN
Brand Name
Care Science
Version/Model Number
00017276236101
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
bdd7f1f7-30ea-4924-970c-2a91b89377d1
Public Version Date
May 26, 2021
Public Version Number
1
DI Record Publish Date
May 18, 2021
Package DI Number
20017276236105
Quantity per Package
18
Contains DI Package
00017276236101
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 |