Duns Number:007138183
Device Description: Coach's Team First Aid Kit: Sterile Eye Pad 1Sterile Eye Wash 10ml 1Butterfly Wound Closu Coach's Team First Aid Kit: Sterile Eye Pad 1Sterile Eye Wash 10ml 1Butterfly Wound Closure 1First Aid Tape Toll 1Bloodstopper Dressing 1CPR Breathing Barrier 1Medical Grade Gloves 2Alcohol Cleansing Pad 1Chewable Aspirin Tablets 2Triangular Bandage 1Instant cold Pack 1Emergency First Air Guide 1Plastic Tweezers 1Assorted Safety Pins 6Adhesive Plastic Bandages” 25Junior Plastic Bandages 3/8” x 1-1/2” 25Adhesive Plastic Bandage 1” x 3” 1Adhesive Spot Bandage 7/8” x 7/8” 1Elbow/Knee Adhesive Bandage 1Burn Cream 1Antiseptic Towelette 2Sterile Gauze Pad 2” x 2” 1Cotton Tipped Applicators 20Pressure Bandage 2” x 2” 1Pressure Bandage 3” x 3” 1
Catalog Number
-
Brand Name
Cramer Sports Medicine Coach's Team First Aid Kit
Version/Model Number
761208
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
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
81b9c9f9-7df7-4861-b9c0-f0640e72a638
Public Version Date
May 01, 2019
Public Version Number
1
DI Record Publish Date
April 23, 2019
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 | 25 |