Molded Products, Inc. - High Temp Female Hansen Connector - Female - MOLDED PRODUCTS, INC.

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

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More Product Details

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

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

K022068,K022068

Product Code Details

Product Code

FID

Product Code Name

Tubing, Dialysate

Device Record Status

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

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