Duns Number:086911794
Device Description: 16 Adhesive Bandage 1 x 3 in.1 Adhesive Tape 2.5 yd (total)10 Antibiotic Application 1/57 16 Adhesive Bandage 1 x 3 in.1 Adhesive Tape 2.5 yd (total)10 Antibiotic Application 1/57 oz10 Antiseptic 1/57 oz1 Breathing Barrier1 Burn Dressing (gel soaked) 4 x 4 in.10 Burn Treatment 1/32 oz1 Cold Pack 4 x 5 in.2 Eye Covering w/ means ofattachment 2.9 sq. in.1 Eye/Skin Wash 1 fl oz total1 First Aid Guide6 Hand Sanitizer 1/32 oz2 pr Medical Exam Gloves1 Roller Bandage 2 in. x 4 yd1 Scissors2 Sterile Pad 3 x 3 in.2 Trauma Pad 5 x 9 in.1 Triangular Bandage 40 x 40 x 56 in.
Catalog Number
733P10P
Brand Name
Medi-First 10 Person Plastic First Aid Kit
Version/Model Number
733P10P
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"
-
For Single-Use
-
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
cb8a2d44-6e7e-4198-bd27-4ea23fb931ec
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
50347682733105
Quantity per Package
12
Contains DI Package
00347682733100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |