Duns Number:086911794
Device Description: 6771B - 2 EACH 4" Compress61270 - 3EACH 3"X3" Sterile Gauze Pads 463775 – 2 EACH 3/4"x3" P 6771B - 2 EACH 4" Compress61270 - 3EACH 3"X3" Sterile Gauze Pads 463775 – 2 EACH 3/4"x3" Plastic Strip 1668999 – 1 EACH 2" Stretch Roller Gauze Unit62612 – 1 EACH Fingertip Woven M/L 10s60075 – 4 EACH 1"X3" Plastic Strip 16s62730 – 1 EACH Woven Knuckle 8s6501B – 2 EACH Triangular Band W/Pins 40"73699 – 1 EACH Disposable Nitrile Gloves 2s Unit22612 – 1 EACH Ammonia Wipes (10)22312 – 2 EACH Triple Antibiotic Ointment 10c21412 - STD 2 EACH Antiseptic Towelettes 5X7 10s22112 – 2 EACH Alcohol Prep Pads 10s72401 – 1 EACH Ice Pack small/boxed77901 - STD 1 EACH Eye Unit (eyewash, tape, pad)47769 - STD 2 EACH Burn Gel w/Lido 6s65699 – 3 EACH 1/2"X2.5yd Adhesive Tape 2s7371B - 1. EACH Forceps and Scissor Unit3060 - 1 EACH BurnAid Dress4x4 +80201 - 1 EACH CPR Mask89801 – 2 EACH ABD Sterile 5x9 1s17378 - 0.006 M Hand Sanitizer Bulk
Catalog Number
36UPA
Brand Name
Medi-First 36 Unit Plastic First Aid Kit
Version/Model Number
36UPA
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
9596cde4-7aa5-429e-bb4b-36a350c53e0b
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
50347682368727
Quantity per Package
10
Contains DI Package
00347682368722
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 |