Duns Number:157506015
Device Description: Recirculation Loop / Rinse Line with Sampling Port
Catalog Number
MPC-660
Brand Name
Molded Products, Inc.
Version/Model Number
MPC-660
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"
Yes
For Single-Use
-
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
K010712,K010712,K010712
Product Code
FID
Product Code Name
Tubing, Dialysate
Public Device Record Key
6dcc246d-ac13-4ced-ab08-16cb5bf71e5b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 04, 2018
Package DI Number
B144MPC6603
Quantity per Package
16
Contains DI Package
B144MPC6601
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |