Duns Number:086911794
Device Description: 21412 - STD 2 EACH Antiseptic Towelettes 5X7 10s22112 – 2 EACH Alcohol Prep Pads 10s22612 21412 - STD 2 EACH Antiseptic Towelettes 5X7 10s22112 – 2 EACH Alcohol Prep Pads 10s22612 – 1 EACH Ammonia Wipes (10)22312 – 2 EACH Triple Antibiotic Ointment 10c47769 - STD 1 EACH Burn Gel w/Lido 6s60075 – 4 EACH 1"X3" Plastic Strip 16s61270 – 3 EACH 3"X3" Sterile Gauze Pads 462612 – 1 EACH Fingertip Woven M/L 10s62730 – 1 EACH Woven Knuckle 8s63775 – 2 EACH 3/4"x3" Plastic Strip 1665699 - 3. EACH 1/2"X2.5yd Adhesive Tape 2s68999 – 1 EACH 2" Stretch Roller Gauze Unit73699 – 1 EACH Disposable Nitrile Gloves 2s Unit77901 - STD 1 EACH Eye Unit (eyewash, tape, pad)6501B – 2 EACH Triangular Band W/Pins 40"6771B – 2 EACH 4" Compress7241B - STD 2 EACH Ice Pack 5"x7"71401 – 1 EACH FIRST AID HANDBOOK
Catalog Number
768P1
Brand Name
Medi-First 36 Unit Plastic First Aid Kit
Version/Model Number
768P1
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
99895390-d7cc-49e9-be6c-54330d123f43
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
50347682768015
Quantity per Package
6
Contains DI Package
00347682768010
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 |