Vivo 1/2, Vivo 3 006977

GUDID 07321820069774

Attachable Humidifier

Breas Medical AB

Heated respiratory humidifier
Primary Device ID07321820069774
NIH Device Record Keyf108f0d9-1477-4460-a8e4-7a3feca3ac67
Commercial Distribution StatusIn Commercial Distribution
Brand NameVivo 1/2, Vivo 3
Version Model Number006977
Catalog Number006977
Company DUNS357007657
Company NameBreas Medical AB
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com
Phone855-436-8724
EmailsupportUS@breas.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107321820069774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-27
Device Publish Date2025-05-19

On-Brand Devices [Vivo 1/2, Vivo 3]

07321820070794SpO2 Adapter cable
07321820070008Accessory Box
07321820069903Heated Wire Patient Circuit
07321820069774Attachable Humidifier
07321820084272Circuit: Single limb 15 mm. Single patient multiple use (30-pack)
07321820084265Circuit: Single limb 22 mm. Single patient multiple use (30-pack)
07321820073801Lightweight Mobility Bag
07321820072033Air Inlet Filter, grey (5pcs)
07321820072026Air Inlet Filter, white (5pcs)
07321820070145Protective Cover
07321820070060Y Cable
07321820067121Circuit: Single limb 15 mm. Single patient multiple use
07321820044658Circuit: Single limb, 22 mm. Single, patient multiple use

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