AccessGUDID - DEVICE: PHILIPS IntelliVue Spirometry Module (00884838020979)

GUDID

Device Identifier (DI) Information

Brand Name: PHILIPS IntelliVue Spirometry Module
Version or Model: IntelliVue Spirometry Module
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 865021
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838020979
Issuing Agency: GS1
Commercial Distribution End Date: January 09, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: IntelliVue Spirometry Module for use with IntelliVue Patient Monitors. The Module allows real-time monitoring of airway flow, airway volume and airway pressure

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
35353	Monitoring spirometer, electrical	A mains electricity (AC-powered) device designed to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. It may also be used to measure the tidal volume, minute volume, and respiration rate delivered to a patient via the expiratory ports of resuscitation devices, such as transport ventilators and resuscitators, to evaluate their performance. The device may incorporate high and low tidal volume alarms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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 Temperature: between -40 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 11 and 107.5 KiloPascal
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f4b8507d-fd88-4000-a280-34677c3b8042
Public Version Date: March 02, 2023
Public Version Number: 3
DI Record Publish Date: October 27, 2016