Molded Products, Inc. - DIALYZER HOLDER - fits 18mm to 22mm IV Pole - MOLDED PRODUCTS, INC.

Duns Number:157506015

Device Description: DIALYZER HOLDER - fits 18mm to 22mm IV Pole

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More Product Details

Catalog Number

MPC-1400A

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-1400A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

-

Product Code Details

Product Code

MON

Product Code Name

System, Hemodialysis, Remote Accessories

Device Record Status

Public Device Record Key

cde975ab-3dc8-4cf9-a834-16fed4363ec4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

B144MPC1400A3

Quantity per Package

15

Contains DI Package

B144MPC1400A2

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MOLDED PRODUCTS, INC." Characteristics
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