Duns Number:170199058
Device Description: All Purpose First Aid Kit, First Aid Essentials, 70 items including 1 carrying case: 5 - F All Purpose First Aid Kit, First Aid Essentials, 70 items including 1 carrying case: 5 - Fabric Antibacterial Bandages 1 IN x 3 IN (25 mm x 76 mm); 10 - Fabric Antibacterial Bandages 3/4 IN x 3 IN (19 mm x 76 mm); 15 - Fabric Antibacterial Bandages 5/8 IN x 2 1/4 IN (15 mm x 57 mm); 8 - Sterile Pads 2 IN x 2 IN (50 mm x 50 mm); 6 - Hand Cleansing Wipes 4.75 IN x 7.75 IN (120 mm x 196 mm); 4 - Antibiotic Ointment 1/32 OZ (0.9 g); 21 - Sheer Antibacterial Bandages 1 IN x 3 IN (25 mm x 76 mm); 1 - Carrying Case
Catalog Number
-
Brand Name
CareOne
Version/Model Number
041520089427
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
4471ab4a-5e9d-47ca-a929-93346cb79d49
Public Version Date
September 08, 2020
Public Version Number
1
DI Record Publish Date
August 31, 2020
Package DI Number
10041520089424
Quantity per Package
36
Contains DI Package
00041520089427
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |
| U | Unclassified | 2 |