Duns Number:961027315
Device Description: CHART PAPER, CARDIAC SCIENCE 15022-001
Catalog Number
8326497
Brand Name
CARDINAL HEALTH
Version/Model Number
8326497
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2021
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
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
DSF
Product Code Name
RECORDER, PAPER CHART
Public Device Record Key
ded598c1-8d8b-4830-9f7f-476f2d2a582c
Public Version Date
June 30, 2021
Public Version Number
3
DI Record Publish Date
June 24, 2019
Package DI Number
50885380112407
Quantity per Package
10
Contains DI Package
30885380112403
Package Discontinue Date
June 30, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |