DEVICE: Breas Vivo 30 System (07321822020001)

Download: XML | JSON

Device Identifier (DI) Information

Breas Vivo 30 System
US
202000
Breas Medical AB
07321822020001
GS1
1
Continuous ventilator
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Portable ventilator, electric A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
MNS Ventilator, Continuous, Non-Life-Supporting
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 20, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07321822020162 1 07321822020001 In Commercial Distribution Box
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4631868860
techsupport@breas.com
CLOSE