DEVICE: i-port ADVANCE™ (05705244009370)
Device Identifier (DI) Information
i-port ADVANCE™
MMT-101T
In Commercial Distribution
Unomedical A/S
MMT-101T
In Commercial Distribution
Unomedical A/S
Single use injection port for subcutaneous injection. The injection port must be used as described in the Instruction for Use.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17180 | Subcutaneous infusion/injection port needle |
A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FOZ | Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store at room temperature. Do not store or leave the device in direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Depth: 9 Millimeter |
Angle: 90 degree |
Device Record Status
7be5c7b9-1177-40fc-9609-2f4511841862
January 11, 2021
4
September 15, 2016
January 11, 2021
4
September 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05705244009387 | 120 | 05705244009370 | In Commercial Distribution | Outer box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
05705244013322
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-646-4633
xx@xx.xx
xx@xx.xx