AccessGUDID - DEVICE: Vyaire (14250892904341)

GUDID

Device Identifier (DI) Information

Brand Name: Vyaire
Version or Model: 36-TDX1043
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 36-TDX1043
Company Name: Jaeger Medical GmbH

Primary DI Number: 14250892904341
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 329769991 *Terms of Use

Device Description: Turbine Complete

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):	No
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?
13680	Diagnostic spirometer, professional	An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZG	Spirometer, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031102	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
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7ab6430b-7bf4-4f5c-8780-98174e197213
Public Version Date: May 28, 2025
Public Version Number: 5
DI Record Publish Date: March 19, 2019

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: +499314972127
Email: support.rt.eu@vyaire.com

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