Duns Number:001180207
Device Description: SmartCompliance Complete First Aid Plastic Cabinet - Contains: Adhesive Fabric Bandages, SmartCompliance Complete First Aid Plastic Cabinet - Contains: Adhesive Fabric Bandages, 1" x 3", 25 ct; Adhesive Plastic Bandages, 0.75" x 3", 25 ct; Alcohol Pads, 20 ct; Antibiotic Ointment Packets, 10 ct; Antiseptic Wipes, 20 ct; Burn Dressing, 4" x 4"; Castille Soap Towellettes, 10 ct; Cold Pack, 4" x 5"; CPR Face Shield; Elastic Bandage Wrap, 2" x 5 yards; Elastic Bandage Wrap, 3" x 5 yd; Eyewash 1 oz bottle; Fingertip Fabric Bandages, 10 ct; First Aid Guide; First Aid Tape 1" x 5 yards; First Aid/Burn Cream Packets, 10 ct; Gauze Roll, 2" x 4 yd; Hand Sanitizer Packets, 10 ct; Moleskin (Blister Prevention), 2" x 2", 20 ct; Nitrile Exam Gloves, 4 ct; Patch Plastic Bandages, 1.5" x 1.5", 10 ct; Scissors; Sterile Eyepads, 2 ct; Sterile Gauze Pads, 2" x 2", 10 ct; Sterile Gauze Pads, 3" x 3", 10 ct; Tape Roll, 0.5 " x 5 yards, 2 ct; Trauma Pads, 5" x 9", 2 ct; Triangular Bandage, 40" x 40" x 56"; Tweezers.
Catalog Number
91093
Brand Name
First Aid Only
Version/Model Number
91093
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
424d3121-832d-4d79-bda0-bb13f0ebd30d
Public Version Date
April 15, 2021
Public Version Number
2
DI Record Publish Date
September 16, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 303 |