Duns Number:001180207
Device Description: American Red Cross Deluxe Family First Aid Kit, Plastic Case. Contains: Adhesive plast American Red Cross Deluxe Family First Aid Kit, Plastic Case. Contains: Adhesive plastic bandages, 1" x 3" (15); Adhesive plastic bandages, 3/4" x 3" (25); American Red Cross Emergency First Aid Guide; Antiseptic wipes (6); Chewable aspirin tablets, 81 mg each (2); Conforming gauze roll bandage, 3"; Conforming gauze roll bandage, 4";CPR one-way valve face shield, latex-free; Elbow and knee plastic bandages, 2" x 4" (3); Emergency blanket; Fingertip fabric bandages (3); First aid tape roll, 1" x 10 yd.; Gauze Dressing Pads, 3" x 3" (6); Gauze dressing pads, 4" x 4" (6); Hydrocortisone cream packs (2); Instant cold compress; Junior adhesive plastic bandages, 3/8" x 1-1/2" (10); Knuckle fabric bandages (3); Latex-free exam-quality vinyl gloves, 2 pairs (4); Patch plastic bandages, 1-1/2" x 1-1/2" (5); Plastic case with dividers; Plastic tweezers; Scissors; Thermometers (one time use) (4); Trauma pads, 5" x 9" (2); Triangular sling/bandages (safety pins included) (2); Triple antibiotic ointment packs (5).
Catalog Number
9161-RC
Brand Name
American Red Cross
Version/Model Number
9161-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
09c52d27-a6cb-4502-a24a-ff6e70036e53
Public Version Date
April 15, 2021
Public Version Number
2
DI Record Publish Date
September 17, 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 |