Duns Number:152793493
Device Description: Professional + All Purpose First Aid Kit: 351 pieces containing medical devices and OTC dr Professional + All Purpose First Aid Kit: 351 pieces containing medical devices and OTC drugs: burn dressing, cold pack, adhesive bandages, butterfly closure, gauze pads, eye pad, trauma pad, CPR breathing barrier, rolled gauze, cotton swabs, paper tape, finger splint, triangular sling, nitrile gloves, scissors, tweezers, alcohol prep pad, antiseptic wipes, hand sanitizer, eye wash, burn gel, antibiotic ointment, acetaminophen, aspirin, ibuprofen and sting relief wipe.
Catalog Number
B07CGFT1FF
Brand Name
Care Science
Version/Model Number
B07CGFT1FF
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
-
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
e79e5be6-1f21-4b22-9420-350b2d87a551
Public Version Date
November 01, 2018
Public Version Number
1
DI Record Publish Date
October 01, 2018
Package DI Number
10017276233596
Quantity per Package
3
Contains DI Package
00017276233599
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 |