Duns Number:152793493
Device Description: Essential, First Aid Kit, 100 pieces: 30 Sheer Bandages - 5/8 IN X 2 1/4 IN (15 MM X 57 MM Essential, First Aid Kit, 100 pieces: 30 Sheer Bandages - 5/8 IN X 2 1/4 IN (15 MM X 57 MM); 20 Sheer Bandages - 3/4 IN X 3 IN (19 MM X 76 MM); 6 Butterfly Closures - 1 3/4 IN X 3/8 IN (44 MM X 9.5 MM); 4 Wooden Finger Splints; 2 Nitrile Gloves; 1 First Aid Guide; 1 Instant Cold Pack; 1 Metal Tweezers; 1 Paper Tape Roll 1/2 IN X 5 YDS (12 MM X 4.5 M); 12 Alcohol Prep Pads - 1 3/16 IN X 2 5/16 IN (30 MM X 58 MM); 10 Triple Antibiotic Ointment - 1/32 OZ (0.9 G); 6 Antiseptic Wipes - 4 3/4 IN X 7 3/4 IN (120 MM X 196 MM); 4 Gauze Pads - 2 IN X 2 IN (50 MM X 50 MM); 2 Gauze Pads - 4 IN X 4 IN (101 MM x 101 MM)
Catalog Number
B08127GKPR
Brand Name
Care Science
Version/Model Number
00017276236545
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
cfbbdfa3-17dc-4be3-98cd-40eaf10c916b
Public Version Date
May 19, 2021
Public Version Number
1
DI Record Publish Date
May 11, 2021
Package DI Number
20017276236549
Quantity per Package
24
Contains DI Package
00017276236545
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 |