AccessGUDID - DEVICE: Molded Products, Inc. (B144MPC1400B2)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc.
Version or Model: MPC-1400B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPC-1400B
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144MPC1400B2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: Dialyzer Holder - fits 22mm to 28mm IV Pole

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?
32144	Haemodialysis system dialyser holder	A device used together with certain types of a haemodialysis system that is used to hold dialysers in order to attach the blood lines from the dialyser to the system. The device is typically made of plastic or stainless steel.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MON	System, Hemodialysis, Remote Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 72b258fa-559c-4e59-aed4-e83c0c5e3e66
Public Version Date: September 12, 2019
Public Version Number: 1
DI Record Publish Date: September 04, 2019