Duns Number:002348191
Device Description: Guardian II NC Torque 25cm Ext
Catalog Number
FH102-25
Brand Name
GUARDIAN
Version/Model Number
IPN914198
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DTL
Product Code Name
Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
Public Device Record Key
52edf6ad-8953-4908-9aad-13c9da7a4a47
Public Version Date
March 05, 2020
Public Version Number
3
DI Record Publish Date
November 08, 2018
Package DI Number
30841156101972
Quantity per Package
25
Contains DI Package
10841156101978
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |