DEVICE: Invisiport 4.4 Fr (00864144000209)

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Device Identifier (DI) Information

Invisiport 4.4 Fr
2000
2000
STEALTH THERAPEUTICS, INC.
00864144000209
GS1
1
Invisiport 4.4 Fr Convenience Kit Contents: Invisiport 4.4Fr Vascular Access Port with Catheter (Not made with natural rubber latex); Microaccess Tear-Away Introducer Set; MicroIntroducer needle; Microguidewire; 20 Gauge, 1.5 inch, Non-Coring Access Needle
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Device Characteristics

MR Conditional
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Infusion/injection port, implantable A sterile metallic and/or non-metallic device intended to be implanted subcutaneously in a patient for the short- or long-term delivery of fluids or medications to the vascular system or other anatomical region. The device consists of a housing with a self-sealing septum and a catheter connection mechanism. The device may be implanted in various anatomical locations. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
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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

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
March 19, 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
No Package DIs found
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Secondary DI

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

[?]
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6082172685
customerservice@stealththerapeutics.com
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