DEVICE: HIGH PRESSURE TUBING (00850004162064)
Device Identifier (DI) Information
HIGH PRESSURE TUBING
VGPMT0501
In Commercial Distribution
VGPMT0501
VALFLUX GROUP, LLC
VGPMT0501
In Commercial Distribution
VGPMT0501
VALFLUX GROUP, LLC
VGPMT0501 HIGH PRESSURE TUBING (30cm)
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? |
---|---|---|---|---|
10689 | Arterial blood pressure catheter |
A sterile, thin flexible tube intended for short-term (<= 30 days) percutaneous placement within an artery for continuous blood pressure monitoring. It is typically interfaced with a parent device (e.g., external blood pressure transducer) and may be used for arterial blood sampling. The catheter is flushed between sampling procedures; it is not intended to be used for the administration of medication or fluids. Devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire, adaptor) may be included. This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXT | INJECTOR AND SYRINGE, ANGIOGRAPHIC |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K170014 | 000 |
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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No Device Sizes |
Device Record Status
f39a8eae-730b-4c1e-87b7-2eed41f38cef
January 18, 2019
1
December 18, 2018
January 18, 2019
1
December 18, 2018
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+556230916442
regulacao@valflux.com.br
regulacao@valflux.com.br