Duns Number:001180207
Device Description: American Red Cross Deluxe Personal First Aid Kit - Contains: Adhesive plastic bandages, American Red Cross Deluxe Personal First Aid Kit - Contains: Adhesive plastic bandages, 1" x 3" (10); Adhesive plastic bandages, 3/4" x 3" (20); American Red Cross First Aid Kit Card; Antiseptic wipes (4); Chewable aspirin tablets, 81 mg each (2); Clear carrying tube,3.875" w x 8.25" h x 2.875" d; Conforming gauze roll bandage, 3" x 3 yd.; Elbow and knee plastic bandages, 2" x 4" (2); Fingertip fabric bandage; First aid tape roll, 1" x 5 yd.; Gauze dressing pads, 3" x 3" (4); Hand sanitizer packs (2); Hydrocortisone cream pack; Junior adhesive plastic bandages, 3/8" x 1-1/2" (5); Knuckle fabric bandage; Latex-free exam-quality vinyl gloves, 1 pair (2); Patch bandage, 1-1/2" (3); Plastic tweezers; Scissors; Trauma pad, 5" x 9"; Triple antibiotic ointment packs (2)
Catalog Number
9164-RC
Brand Name
American Red Cross
Version/Model Number
9164-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
00ddbce5-21af-4d7c-b306-4b66ad016cb1
Public Version Date
April 15, 2021
Public Version Number
2
DI Record Publish Date
October 14, 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 |