Duns Number:152793493
Device Description: First Aid Kit 351 pieces including 1 carrying case: 30 Butterfly Closures 1 3/4 IN X 3/8 I First Aid Kit 351 pieces including 1 carrying case: 30 Butterfly Closures 1 3/4 IN X 3/8 IN (44 MM X 9.5 MM); 30 Fabric Bandages 3/4 IN X 3 IN (19 MM X 76 MM); 30 Sheer Bandages 3/4 IN X 3 IN (19 MM X 76 MM); 28 Sheer Spot Bandages 7/8 IN (22 MM); 25 Fabric Bandages 1 IN X 3 IN (25 MM X 76 MM); 25 Sheer Bandages 1 IN X 3 IN (25 MM X 76 MM); 20 Sheer Bandages 5/8 IN X 2 1/4 IN (15 MM X 57 MM); 20 Fabric Bandages 5/8 IN X 2 1/4 IN (15 MM X 57 MM); 10 Fabric Fingertip Bandages 1 3/4 IN X 2 IN (44 MM X 50 MM); 10 Fabric Knuckle Bandages 1 1/2 IN X 3 IN (38 MM X 76 MM); 2 Fabric Extra Large Bandages 2 IN X 4 IN (50 MM X 101 MM); 2 Sheer Adhesive Bandages 2 1/4 IN X 3 IN (57 MM X 76 MM); 5 Wooden Finger Splints; 4 Nitrile Exam Gloves; 2 Paper Tape Rolls 1 IN X 5 YDS (25 MM X 4.5 M); 2 Paper Tape Rolls 1 IN X 10 YDS (25 MM X 9 M); 1 Breathing Barrier; 1 Carrying Case; 1 First Aid Guide; 1 Instant Cold Pack; 1 Metal Scissors; 1 Metal Tweezers; 1 Tender Tape 1 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); 10 Alcohol Prep Pads 1 3/16 IN X 2 5/16 IN (30 MM X 58 MM); 10 Antiseptic Wipes 4 3/4 IN X 7 3/4 IN (120 MM X 196 MM); 10 Hand Cleansing Wipes 4 3/4 IN X 7 3/4 IN (120 MM X 196 MM); 10 Hand Sanitizers 1/32 OZ (0.9 G); 10 Hydrocortisone Cream 1/32 OZ (0.9 G); 10 Triple Antibiotic Ointments 1/32 OZ (0.9 G); 4 Ibuprofen; 2 Acetaminophen (Non-Aspirin); 8 Gauze Pads 2 IN X 2 IN (50 MM X 50 MM); 8 Gauze Pads 3 IN X 3 IN (76 MM X 76 MM); 8 Gauze Pads 4 IN X 4 IN (101 MM X 101 MM); 2 Rolled Gauze 3 IN X 2 1/2 YDS (76 MM x 2.2 M); 2 Eye Cover Pad2.25 IN X 3.03 IN (57 MM x 77 MM); 2 Transparent Dressings 2.36 IN X 2.75 IN (59 MM X 69 MM); 1 Rolled Gauze 2 IN X 2 1/2 YDS (50 MM x 2.2 M); 1 Trauma Pad5 IN X 9 IN (127 MM x 228 MM).
Catalog Number
B08JS1LBRX
Brand Name
Care Science
Version/Model Number
00017276237368
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
17df1ab7-a9bc-46da-9985-3e23ee1384b1
Public Version Date
May 19, 2021
Public Version Number
1
DI Record Publish Date
May 11, 2021
Package DI Number
20017276237362
Quantity per Package
3
Contains DI Package
00017276237368
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 |