AccessGUDID - DEVICE: Jaeger (04250892900773)

GUDID

Device Identifier (DI) Information

Brand Name: Jaeger
Version or Model: V-175423
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: V-175423
Company Name: Vyaire Medical GmbH

Primary DI Number: 04250892900773
Issuing Agency: GS1
Commercial Distribution End Date: May 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 329769991 *Terms of Use

Device Description: MasterScreen Body/Diff

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?
35242	Whole-body plethysmograph	A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZC	Calculator, Pulmonary Function Data

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
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5f641bc7-f7d7-40ff-b65b-05ae9960e05e
Public Version Date: March 16, 2021
Public Version Number: 5
DI Record Publish Date: September 16, 2016