DEVICE: Molded Products, Inc. (B144MPC875NS1)
Device Identifier (DI) Information
Molded Products, Inc.
MPC-875NS
In Commercial Distribution
MPC-875NS
MOLDED PRODUCTS, INC.
MPC-875NS
In Commercial Distribution
MPC-875NS
MOLDED PRODUCTS, INC.
Non-Sterile Blood Line Extension
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| Yes | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 63952 | Haemodialysis system dialysate delivery set |
A collection of non-powered, non-sterile devices intended to be integrated within a haemodialysis system to allow for mixing and delivery of dialysate solution from a powered delivery unit (not included) to the dialyser (not included). The set includes mixing chambers to allow the dialysate to be mixed from a concentrate solution, pumping reservoirs designed to be compressed by an actuator(s) within the delivery unit to displace the dialysate, and an array of tubing/connectors; it is intended to be used in the home and healthcare settings. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FID | Tubing, Dialysate |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K010712 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
494ec535-ca32-4a23-b42f-4674885f8aa2
September 12, 2019
1
September 04, 2019
September 12, 2019
1
September 04, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| B144MPC875NS3 | 30 | B144MPC875NS1 | In Commercial Distribution | Case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
B144MPC875NS0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined