Duns Number:788403103
Device Description: The Stableline is designed to stabilize and contain one to six tubing lines of varying siz The Stableline is designed to stabilize and contain one to six tubing lines of varying sizes which connect cardiopulmonary bypass equipment for delivery or return of fluids to and from the surgical field. The product attaches to the surgical drapes and prevents the tubing lines from slipping, while keeping them out of the way of appropriate procedures. This component is a disposable, single use item.
Catalog Number
-
Brand Name
Stableline Tubing Organizer (Non Sterile)
Version/Model Number
5000N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 17, 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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KRI
Product Code Name
Accessory Equipment, Cardiopulmonary Bypass
Public Device Record Key
f2a94d9b-6126-4876-af1d-dde071d6f0f6
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
July 15, 2016
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |