AccessGUDID - DEVICE: Molded Products, Inc. (B144MPC852)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: B144MPC852
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 300
Labeler D-U-N-S® Number*: 157506015 *Terms of Use

Device Description: Dialysis Transducer Protector

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: 5c7f1693-4727-4ff9-b2cd-f1105e779a32
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 04, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B144MPC853	25	B144MPC852		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: B144MPC850 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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