Duns Number:152793493
Device Description: All-Purpose First Aid Kit: 200 pieces containing medical devices and OTC drugs: cotton tip All-Purpose First Aid Kit: 200 pieces containing medical devices and OTC drugs: cotton tipped applicator, nitrile gloves, wooden finger splint, cold pack, metal tweezers, scissors, antiseptic wipes, acetaminophen, aspirin, ibuprofen, alcohol prep pad, sting relief wipe, antibiotic ointment, burn gel, adhesive bandages, gauze pads, non-stick pad, gauze pad, paper tape, rolled gauze, surgical pad.
Catalog Number
017276234176
Brand Name
Care Science
Version/Model Number
017276234176
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
f05d2eeb-812b-472f-ad40-5e88b583237d
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 28, 2019
Package DI Number
10017276234173
Quantity per Package
18
Contains DI Package
00017276234176
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 |