DEVICE: Firesafe Connector Kit (00848530062125)
Device Identifier (DI) Information
Firesafe Connector Kit
RES010KIT
In Commercial Distribution
RES010KIT
SUNSET HEALTHCARE SOLUTIONS, INC.
RES010KIT
In Commercial Distribution
RES010KIT
SUNSET HEALTHCARE SOLUTIONS, INC.
This kit contains: 2 RES010 Firesafe Bidirectional Thermal Shut-Off Cannula Valves, 1 RES010TC Firesafe Tubing Connector.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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60391 | Oxygen tubing fire safety valve |
A safety device intended to be integrated into oxygen delivery tubing to automatically stop the flow of oxygen and isolate the oxygen supply in the event of a fire. It typically consists of a small two-way tubing connector containing a thermal fuse. This is a single-patient, reusable device.
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Active | false |
FDA Product Code
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No Product Codes |
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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No Device Sizes |
Device Record Status
3c06b7c3-9468-4ffa-9e3e-b9dc7c3f0582
September 09, 2020
2
July 31, 2018
September 09, 2020
2
July 31, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
877-578-6738
customerservice@sunsethcs.com
customerservice@sunsethcs.com