AccessGUDID - DEVICE: Vivo 1/2 (07321822270000)

GUDID

Device Identifier (DI) Information

Brand Name: Vivo 1/2
Version or Model: Vivo 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 227500
Company Name: Breas Medical AB

Primary DI Number: 07321822270000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 357007657 *Terms of Use

Device Description: Ventilator, Continuous, Non-Life-Supporting

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47083	Portable electric ventilator	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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNS	Ventilator, Continuous, Non-Life-Supporting
NOU	Continuous, Ventilator, Home Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240778	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b237241c-c8d9-4a6a-9543-e3d5d1342e72
Public Version Date: May 27, 2025
Public Version Number: 1
DI Record Publish Date: May 19, 2025

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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 855-436-8724
Email: supportUS@breas.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES