AccessGUDID - DEVICE: ExSpiron 2Xi (00851540007147)

GUDID

Device Identifier (DI) Information

Brand Name: ExSpiron 2Xi
Version or Model: RMI-54000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Senzime AB (Publ.)

Primary DI Number: 00851540007147
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559976316 *Terms of Use

Device Description: A noninvasive device designed to continuously measure a patient's tidal volume, minute ventilation, and respiratory rate via impedance pneumography. Designed to be connected to the ExSpiron PadSet via the ExSpiron Patient Cable, the ExSpiron 2Xi Monitor provides a measurement of a patient's respiratory parameters, while also incorporating alarms. The ExSpiron 2Xi Monitor can be integrated into a medical facility's nurse call system.

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
BZQ	Monitor, Breathing Frequency
BZK	Spirometer, Monitoring (W/Wo Alarm)

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 -20 and 65 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 80 and 101 KiloPascal
Handling Environment Temperature: between 5 and 32 Degrees Celsius
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 101 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec43e40b-7201-43eb-aada-df2ba4e71109
Public Version Date: July 24, 2024
Public Version Number: 5
DI Record Publish Date: January 06, 2020