AccessGUDID - DEVICE: Vivo 50, Vivo 65, Vivo 45 LS (07321820050321)

GUDID

Device Identifier (DI) Information

Brand Name: Vivo 50, Vivo 65, Vivo 45 LS
Version or Model: 005032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 005032
Company Name: Breas Medical AB

Primary DI Number: 07321820050321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 357007657 *Terms of Use

Device Description: Oxygen adapter low pressure

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
37038	Ventilator converter	A device intended to be used to couple together any type of powered ventilator to any kind of breathing circuit system, making them compatible for use. By using this device it is then possible to use alternative combinations of ventilator and breathing circuit from different manufacturers. This will assist, e.g., a hospital to be flexible in the choice of breathing circuit or system and allowing for the introduction to new kinds whilst the ventilators may remain the same. This is a reusable device.	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 [?]
Premarket Submission Number Not Available/Not Released

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: db451dd0-137e-4e39-9f7f-15f00e31c368
Public Version Date: December 26, 2022
Public Version Number: 2
DI Record Publish Date: 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
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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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