Duns Number:001180207
Device Description: American Red Cross CPR Station - Contains Antimicrobial wipes (4), Backboard with mounting American Red Cross CPR Station - Contains Antimicrobial wipes (4), Backboard with mounting materials, Biohazard Bag w/ twist tie, CPR card – English, CPR card – Spanish, CPR face shields w/ one-way valve (4), Exam quality latex free vinyl gloves (8)
Catalog Number
9145-RC
Brand Name
American Red Cross
Version/Model Number
9145-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
a6594c25-ce82-41e4-ab96-afce5edfca65
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 |