AccessGUDID - DEVICE: Vivatmo pro Level 0 (04059233000307)

GUDID

Device Identifier (DI) Information

Brand Name: Vivatmo pro Level 0
Version or Model: F09G100230
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F09G100230
Company Name: Bosch Healthcare Solutions GmbH

Primary DI Number: 04059233000307
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 341189007 *Terms of Use

Device Description: Disposable mouthpiece for Vivatmo

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:	Yes
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?
65819	Electrochemical breath analyser filter/mouthpiece IVD	A device designed as a breathing mouthpiece and filter intended to be attached to an in vitro diagnostic electrochemical breath analyser to facilitate exhaled air specimen sampling and accurate measurement of target chemical and/or biological markers. It has an integrated reactive filtering material to remove potentially confounding species (e.g., ammonia, methanol) and to chemically prepare the specimen for measurement [e.g., via oxidation]; it may also be designed to remove target particles to provide a control baseline measurement. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MXA	System, Test, Breath Nitric Oxide

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
Handling Environment Humidity: between 15 and 60 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry
Handling Environment Atmospheric Pressure: between 78 and 110 KiloPascal
Handling Environment Temperature: between 15 and 27 Degrees Celsius
Storage Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a90df9b6-610d-4f17-bf6c-aef0237c70ad
Public Version Date: July 16, 2024
Public Version Number: 1
DI Record Publish Date: July 08, 2024