Duns Number:007138183
Device Description: Coach's First Aid Kit- (15) Adhesive Plastic Bandages 3/4" x 3", (20) Junior Adhesive Plas Coach's First Aid Kit- (15) Adhesive Plastic Bandages 3/4" x 3", (20) Junior Adhesive Plastic Bandages 3/8" x 1-1/2", (3) Adhesive Plastic Bandages 1" x 3", (15) Adhesive Spot Bandages 7/8"x7/8", (1) Knuckle Fabric Bandage, (1) Fingertip Fabric Bandage, (1) Elbow/Knee Adhesive Bandage, (2) Butterfly Wound Closures, (1) Triangular Bandage 4"x 4"x 5", (2) Sterile Gauze Pads 2"x2", (1) Pressure Bandage 2"x 2", (1) Pressure Bandage 3"x 3", (1) First Aid Tape Roll 1/2"x2.5yds, (1) Instant Ice Pack, (2) Alcohol Cleansing Pads, (4) Antiseptic Towelettes, (1) CPR Breathing Barrier, (1) Emergency First Aid Guide, (6) Assorted Safety Pins, (2) Medical Grade Vinyl Gloves, (1) Burn Cream, (1) Triple Antibiotic Ointment 0.9g, (10) Cotton Tipped Applicators, (1) Blood Stopper Dressing, (1) Sterile Eye Pad, (1) Sterile Eye Wash 10ml, (2) Chewable Aspirin Tablets
Catalog Number
-
Brand Name
Cramer Sports Medicine Coach's First Aid Kit
Version/Model Number
761206
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
f321defa-14b6-49cf-a860-c731d14e1108
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 |