DEVICE: i-port ADVANCE™ (05705244009356)

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Device Identifier (DI) Information

i-port ADVANCE™
MMT-100T

Unomedical A/S
05705244009356
GS1
2
Single use injection port for subcutaneous injection. The injection port 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

[?]

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

GMDN Preferred Term Name GMDN Definition
Subcutaneous injection/infusion port needle A sterile, sharp bevel-edged, hollow tubular metal instrument attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FOZ Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days
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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
Special Storage Condition, Specify: Store at room temperature. Do not store or leave the device in direct sunlight
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Clinically Relevant Size

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Size Type Text
Depth: 6 Millimeter
Angle: 90 degree
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Device Status

In Commercial Distribution
September 15, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05705244009363 120 05705244009356 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: 05705244013315 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

[?]
1-800-646-4633
xx@xx.xx
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