Duns Number:961027315
Device Description: CRD/GUARDIAN TANDEM TUBE 18"
Catalog Number
65652-542A
Brand Name
CARDINAL HEALTH
Version/Model Number
65652-542A
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
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
GAZ
Product Code Name
TUBING, NONINVASIVE
Public Device Record Key
76874967-5bbf-44c3-9e74-71c4cd8bebf0
Public Version Date
June 08, 2021
Public Version Number
4
DI Record Publish Date
March 05, 2021
Package DI Number
50885380179318
Quantity per Package
30
Contains DI Package
20885380179317
Package Discontinue Date
-
Package Status
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 |