Duns Number:001180207
Device Description: Be Red Cross Ready First Aid Kit Contains - American Red Cross Emergency First Aid Guid Be Red Cross Ready First Aid Kit Contains - American Red Cross Emergency First Aid Guide; Antiseptic wipes (sting free) (4); chewable aspirin tablets, 81 mg each (2); CPR one-way valve face shield, latex-free; Elbow and knee plastic bandages, 2" x 4" (2); Fingertip fabric bandage; First aid tape roll, 3/4" x 5 yards; Gauze dressing pads, 3" x 3" (4); Gauze dressing pads, 4" x 4" (2); Gauze roll bandage, 3"; Hand sanitizer packs (2); Hydrocortisone pack; Instant cold compress; Junior plastic bandages, 3/8" x 1-1/2" (5); Knuckle fabric bandage; Latex-free exam-quality vinyl gloves (2); Patch bandages, 1-1/2" x 1-1/2" (3); Plastic adhesive bandages, 3/4" x 3" (20); Plastic adhesive bandages,1" x 3" (10); Plastic tweezers; Scissors; Thermometer, one time use; Trauma pad, 5" x 9"; Triangular sling/bandage; Triple Antibiotic Ointment Pack (3); Zippered clear-pocket soft pack.
Catalog Number
9165-RC
Brand Name
American Red Cross
Version/Model Number
9165-RC
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
759df2d1-9784-4374-9ce4-36d329f52608
Public Version Date
April 15, 2021
Public Version Number
2
DI Record Publish Date
September 18, 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 |