DEVICE: Molded Products, Inc. (B144MPC124B0)

Device Identifier (DI) Information

Molded Products, Inc.
MPC-124-B
In Commercial Distribution
MPC-124-B
MOLDED PRODUCTS, INC.
B144MPC124B0
HIBCC

1
157506015 *Terms of Use
Luer Lock Cap
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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
Vascular catheter disinfection cap A sterile (or with sterile fluid path) cap intended to be placed on one of the alternative connectors in an intravenous line (e.g., needleless valve, Luer access valve, male Luer connector) to disinfect the valve surface and/or maintain disinfection, and for protection. It is a synthetic polymer cap containing a foam material saturated with isopropyl alcohol (IPA) as the disinfectant; it may contain other components. The cap may be removed shortly after disinfection, or remain in place to maintain disinfection for a limited period. This device may be supplied with male Luer end caps (not containing disinfectant) for use on the disconnected IV tubing. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FPA Set, Administration, Intravascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K925927 000
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Sterilization

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

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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

11a0ca02-2b60-4c04-b6e6-2529080de7f4
July 06, 2018
3
September 08, 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
B144MPC124B3 25 B144MPC124B2 In Commercial Distribution Case
B144MPC124B2 3 B144MPC124B1 In Commercial Distribution Box
B144MPC124B1 100 B144MPC124B0 In Commercial Distribution Bag
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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