Duns Number:086911794
Device Description: 17378 - 0.006 M Hand Sanitizer Bulk20669 - 1 EACH Burn Cream w/Lidocaine Unit (121412 - ST 17378 - 0.006 M Hand Sanitizer Bulk20669 - 1 EACH Burn Cream w/Lidocaine Unit (121412 - STD 2 EACH Antiseptic Towelettes 5X7 10s22312 – 2 EACH Triple Antibiotic Ointment 10c3060 - 1 EACH BurnAid Dress4x460075 – 4 EACH 1"X3" Plastic Strip 16s61270 – 3 EACH 3"X3" Sterile Gauze Pads 462730 – 1 EACH Woven Knuckle 8s63775 – 2 EACH 3/4"x3" Plastic Strip 166501B – 2 EACH Triangular Band W/Pins 40"68999 – 1 EACH 2" Stretch Roller Gauze Unit71401 – 1 EACH FIRST AID HANDBOOK72401 - 1 EACH Ice Pack small/boxed EACH73699 – 1 EACH Disposable Nitrile Gloves 2s Unit7371B - 1 EACH Forceps and Scissor Unit77901 - STD 1 EACH Eye Unit (eyewash, tape, pad)80201 – 1 EACH CPR Mask89801 - 2 EACH ABD Sterile 5x9 1s
Catalog Number
16UMA
Brand Name
Medi-First 16 Unit Metal First Aid Kit
Version/Model Number
16UMA
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
d04c4acd-86ce-4965-b052-c23b4b281797
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
50347682168624
Quantity per Package
12
Contains DI Package
00347682168629
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 |