Duns Number:086911794
Device Description: 19818 - STD 1 EACH Mediwash eyewash 4oz24402 – 1 EACH MF Antiseptic Spray 2oz Pump22502 – 19818 - STD 1 EACH Mediwash eyewash 4oz24402 – 1 EACH MF Antiseptic Spray 2oz Pump22502 – 1 EACH MF Burn Spray Pump 2oz221B - 0.002 M ALCOHOL PREP PADS-BULK223B - 0.003 M MF TRIPLE ANTIBIOTIC .5gr BULK60501 – 1 EACH 2" StrleConformGauze1s60612 - STD 1 EACH 2"x2" Sterile Gauze Pad10s60701 – 1 EACH Adhesive Tape 1/2 x5 yd61450 – 1 EACH HW 7/8"X3" Woven Strip 50s64101 - 1 EACH Bloodstopper Compress 9X5 (1s)643B - 0.005 M HW Latex Free Woven Fingertip BULK645B - 0.005 M HW Latex Free Woven Knuckle BULK65001 - 1 EACH Tri cut Bandage non-sterile 1s + pins75599 - 2 EACH Disposable Vinyl Gloves Pair/L71401 - 1 EACH FIRST AID HANDBOOK72401 – 1 EACH Ice Pack small/boxed EACH77101 - 1 EACH WIRE SCISSORS 4.5"77233 - 0.010 ECH Disposable Tweezers 100/bag805B - STD 0.010 M MF/MFP ASPIRIN BULK
Catalog Number
807M1
Brand Name
Medi-First Large Vehicle Metal First Aid Kit
Version/Model Number
807M1
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
1cbc7d04-4b70-4dbc-ae69-58426f2ec040
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
Package DI Number
50347682807011
Quantity per Package
6
Contains DI Package
00347682807016
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 |