Molded Products, Inc. - Single Safety Adapter with Rotating Fitting - MOLDED PRODUCTS, INC.

Duns Number:157506015

Device Description: Single Safety Adapter with Rotating Fitting

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More Product Details

Catalog Number

MPC-710F

Brand Name

Molded Products, Inc.

Version/Model Number

MPC-710F

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

K010712,K010712,K010712

Product Code Details

Product Code

FID

Product Code Name

Tubing, Dialysate

Device Record Status

Public Device Record Key

30a030ab-afe8-4b1f-b223-4242c474a34c

Public Version Date

September 12, 2019

Public Version Number

1

DI Record Publish Date

September 04, 2019

Additional Identifiers

Package DI Number

B144MPC710F3

Quantity per Package

20

Contains DI Package

B144MPC710F1

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