Molded Products, Inc. - In-Series Tandem Dialysate Line - White - MOLDED PRODUCTS, INC.

Duns Number:157506015

Device Description: In-Series Tandem Dialysate Line - White

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More Product Details

Catalog Number

MPC-725A-W

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-725A-W

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

Yes

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

Product Code Details

Product Code

FID

Product Code Name

Tubing, Dialysate

Device Record Status

Public Device Record Key

8564a9ee-ea4b-4567-aa62-a2190843da7c

Public Version Date

September 12, 2019

Public Version Number

1

DI Record Publish Date

September 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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