Duns Number:812560399
Device Description: This blood tubing set accessory is intended for single use in a hemodialysis treatment. It This blood tubing set accessory is intended for single use in a hemodialysis treatment. It may be used either as a recirculation adapter during use to connect the arterial and venous patient together or as a means to connect the blood tubing set to the Waste Handling Option (WHO) on Phoenix machines during prime.
Catalog Number
106283
Brand Name
Recirculation Adapter/Priming Connector
Version/Model Number
106283
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
K070414,K070414
Product Code
FJK
Product Code Name
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Public Device Record Key
d1105f7a-c208-408f-8107-19e51ce4d1e1
Public Version Date
October 11, 2022
Public Version Number
5
DI Record Publish Date
October 23, 2015
Package DI Number
37332414055180
Quantity per Package
100
Contains DI Package
07332414055189
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |