Duns Number:152793493
Device Description: First Aid Kit, 30 pieces, 2- Hand Sanitizers 1/32 OZ (0.9 G); 24 - 3/4” Crayon Shaped Band First Aid Kit, 30 pieces, 2- Hand Sanitizers 1/32 OZ (0.9 G); 24 - 3/4” Crayon Shaped Bandages 0 .75 IN X 2.8 IN (19mm x 71mm); 2- Hand Cleansing Wipes 4 3/4 IN X 7 3/4 IN (12 cm x 19.6 cm); 2- Triple Antibiotic Ointments 1/32 OZ (0.9 G)
Catalog Number
-
Brand Name
Crayola
Version/Model Number
017276237801
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
5845fca1-b3ef-4313-8dc2-7f17e506603d
Public Version Date
June 08, 2021
Public Version Number
1
DI Record Publish Date
May 31, 2021
Package DI Number
20017276237805
Quantity per Package
24
Contains DI Package
00017276237801
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 |