AccessGUDID - DEVICE: Molded Products, Inc. (B144MPC7421)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc.
Version or Model: MPC-742
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPC-742
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144MPC7421
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: Male Hansen Connector to Female Quick Disconnect Adapter

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 81c244a2-3a07-4827-aadb-00b5d20fcab1
Public Version Date: September 12, 2019
Public Version Number: 1
DI Record Publish Date: September 04, 2019