AccessGUDID - DEVICE: Molded Products, Inc. (B144MPC7281)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc.
Version or Model: MPC-728
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPC-728
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144MPC7281
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: Dialysate Line with Flow Restrictor

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):	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?
58093	Haemodialysis treatment kit	A collection of sterile and disposable/consumable devices intended to be used to prepare for and perform a haemodialysis treatment with a haemodialysis system. It typically consists of tubing, haemodialysis dialysers, dialysate concentrates, and rinsing solutions for preparation of the extracorporeal circuit. 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 [?]
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: 8d66956c-6d80-4694-b711-a8c9739aca29
Public Version Date: September 12, 2019
Public Version Number: 1
DI Record Publish Date: September 04, 2019