DEVICE: Quick-set® Paradigm® (05705244006553)

Device Identifier (DI) Information

Quick-set® Paradigm®
MMT-386600
In Commercial Distribution

Unomedical A/S
05705244006553
GS1

10
306032491 *Terms of Use
Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.
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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
Electric infusion pump administration set, single-use A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. 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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle.
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Clinically Relevant Size

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Size Type Text
Length: 80 Centimeter
Depth: 9 Millimeter
Angle: 90 degree
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Device Record Status

66ba8d4a-bb83-40f2-9412-20baebfc1734
March 29, 2018
2
September 15, 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
05705244006560 100 05705244006553 In Commercial Distribution Outer box
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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: 05705244011762 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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1-800-646-4633
xx@xx.xx
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