DEVICE: Molded Products, Inc. (B144MPC85TE2)

Device Identifier (DI) Information

Molded Products, Inc.
MPC-85TE
In Commercial Distribution
MPC-85TE
MOLDED PRODUCTS, INC.
B144MPC85TE2
HIBCC

125
157506015 *Terms of Use
DIALYSIS TRANSDUCER PROTECTOR - Tamper Evident Packaging
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
FIB Protector, Transducer, Dialysis
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FDA Premarket Submission

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

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

2d26f2b0-1c05-4be3-8a21-75452f1b4494
July 06, 2018
3
December 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B144MPC85TE3 22 B144MPC85TE2 In Commercial Distribution Case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: B144MPC85TE0 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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