Duns Number:157506015
Device Description: High Temp Female Hansen Connector - Female Dialysate Connection Connector - Barbed - fits High Temp Female Hansen Connector - Female Dialysate Connection Connector - Barbed - fits 1/8" ID Tubing, Red
Catalog Number
MPC-784-R
Brand Name
Molded Products, Inc.
Version/Model Number
MPC-784-R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K022068,K022068
Product Code
FID
Product Code Name
Tubing, Dialysate
Public Device Record Key
d819cb2a-ed38-44a0-92a7-2e42b27430d9
Public Version Date
September 11, 2019
Public Version Number
1
DI Record Publish Date
September 03, 2019
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |