DEVICE: Vivo 45 LS, Vivo 65 (07321820063604)
Device Identifier (DI) Information
Vivo 45 LS, Vivo 65
006360
In Commercial Distribution
006360
Breas Medical AB
006360
In Commercial Distribution
006360
Breas Medical AB
Remote alarm cable, 25 m
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
62168 | Nurse call system alarm |
An electronic device intended to provide an audible sound and/or a visual display, typically coloured flashing lights or scrolling text, to notify a medical professional that (urgent) assistance is needed by a patient. It may be in the form of dome lights, basic visual display screens, and/or beeping devices which are triggered by manual or automatic alert activators (e.g., bedside push-button, ambulatory fall sensor, bed occupancy sensor) [not included]; it may function independently or as a component of a nurse call system via the healthcare facility hardwired or wireless network.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CBK | Ventilator, Continuous, Facility Use |
NOU | Continuous, Ventilator, Home Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160481 | 000 |
K193586 | 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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Length: 25 Meter |
Device Record Status
61cd42d7-4c74-4e95-a7ac-91d2730f5a83
June 27, 2022
1
June 18, 2022
June 27, 2022
1
June 18, 2022
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 |
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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
[?]
855-436-8724
supportUS@breas.com
supportUS@breas.com