DEVICE: Vivo 45 LS, Vivo 65 (07321820063604)

Device Identifier (DI) Information

Vivo 45 LS, Vivo 65
006360
In Commercial Distribution
006360
Breas Medical AB
07321820063604
GS1

1
357007657 *Terms of Use
Remote alarm cable, 25 m
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CBK Ventilator, Continuous, Facility Use
NOU Continuous, Ventilator, Home Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K160481 000
K193586 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 25 Meter
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Device Record Status

61cd42d7-4c74-4e95-a7ac-91d2730f5a83
June 27, 2022
1
June 18, 2022
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
855-436-8724
supportUS@breas.com
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