Duns Number:006261481
Device Description: CANNULA 96530-021 BIO-MED ART 21FR 17L
Catalog Number
-
Brand Name
BIO-MEDICUS™
Version/Model Number
96530-021
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K884129
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
447e7298-e513-4dca-8dbf-f9c8b37e8d41
Public Version Date
September 26, 2022
Public Version Number
5
DI Record Publish Date
February 12, 2018
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |