AccessGUDID - DEVICE: Molded Products, Inc. (B144MPC6701)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc.
Version or Model: MPC-670
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPC-670
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144MPC6701
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: Dialyzer Pre-Rinse System

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:	Yes
Prescription Use (Rx):	Yes
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?
47071	Hollow-fibre haemodialysis dialyser, reusable	A filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-patient, reusable device after high-level disinfection.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FID	Tubing, Dialysate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K022068	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: 64d8f539-329b-489e-a60a-7f65a431caf9
Public Version Date: September 05, 2019
Public Version Number: 4
DI Record Publish Date: December 16, 2016