DEVICE: ExSpiron (00851540007017)
Device Identifier (DI) Information
ExSpiron
Patient Cable, 8'
In Commercial Distribution
RMI-51130
Respiratory Motion Inc.
Patient Cable, 8'
In Commercial Distribution
RMI-51130
Respiratory Motion Inc.
Noninvasive, insulated, electrical cable designed to connect the ExSpiron Monitor to the ExSpiron PadSet.
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 5 and 32 Degrees Celsius |
Storage Environment Temperature: between -20 and 65 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e319fb3e-6294-49fb-8c59-a37d1ab85dd4
September 25, 2023
6
September 24, 2016
September 25, 2023
6
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00851540007093 | 1 | 00851540007017 | In Commercial Distribution | Outer Case |
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-213-1324
info.us@senzime.com
info.us@senzime.com