AccessGUDID - DEVICE: TransAir3 (05407003162011)

GUDID

Device Identifier (DI) Information

Brand Name: TransAir3
Version or Model: TransAir3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-SA-03-TA
Company Name: Medi Soft SA

Primary DI Number: 05407003162011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 393789540 *Terms of Use

Device Description: Pulmonary Function Testing Device, intended for measuring lung volumes by spirometry and Helium dilution

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?
35282	Pulmonary function analysis system, adult	A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZC	Calculator, Pulmonary Function Data

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953990	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
Handling Environment Atmospheric Pressure: between 800 and 1200 millibar
Handling Environment Humidity: between 25 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Atmospheric Pressure: between 800 and 1200 millibar
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -45 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 63359a1c-23dc-4d5e-b3a0-2c39995388fa
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 2016