DEVICE: Corsair Armet (04547327108225)
Device Identifier (DI) Information
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 |
---|---|
Peripheral/coronary vascular infusion catheter | A sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral and coronary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], and may include an inflatable balloon designed specifically to isolate a specific region of coronary or peripheral vasculature from blood flow while allowing infusion into that region. It is not a peripherally-inserted central venous catheter, nor a microcatheter intended for access into superselective small vessels. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
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DQY | CATHETER, PERCUTANEOUS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 2.3 French |
Length: 150 Centimeter |
Device Record Status
ac2d0366-7a30-4d44-a3b9-4691f07df8c5
March 29, 2018
2
September 16, 2016
March 29, 2018
2
September 16, 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 |
---|---|---|---|---|---|
24547327108229 | 1 | 04547327108225 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined