AccessGUDID - DEVICE: Molded Products, Inc. (B144MPC85TE2)

GUDID

Device Identifier (DI) Information

Brand Name: Molded Products, Inc.
Version or Model: MPC-85TE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MPC-85TE
Company Name: MOLDED PRODUCTS, INC.

Primary DI Number: B144MPC85TE2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 125
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: DIALYSIS TRANSDUCER PROTECTOR - Tamper Evident Packaging

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?
32109	Haemodialysis system transducer protector	A sterile device designed to protect a haemodialysis system pressure monitor and to help maintain the sterility of the blood tubing fluid pathway. It is typically attached between the blood tubing set and the pressure monitor and typically consists of plastic housing that contains a hydrophobic filter with a reference pore size (e.g., 1 to 2 microns) that helps prevent cross-contamination by viruses, bacteria, and particulate matter while preventing the flow of fluids to the pressure monitor. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIB	Protector, Transducer, Dialysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K925978	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 2d26f2b0-1c05-4be3-8a21-75452f1b4494
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 16, 2016