DEVICE: ExSpiron 1Xi (00851540007017)

Device Identifier (DI) Information

ExSpiron 1Xi
Patient Cable, 8'
In Commercial Distribution
RMI-51130
RESPIRATORY MOTION INC.
00851540007017
GS1

1
963613745 *Terms of Use
Noninvasive, insulated, electrical cable designed to connect the ExSpiron 1Xi Monitor to the ExSpiron 1Xi PadSet.
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Electrical-only medical device connection cable, reusable A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
BZQ Monitor, Breathing Frequency
BZK Spirometer, Monitoring (W/Wo Alarm)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 5 and 32 Degrees Celsius
Storage Environment Temperature: between -20 and 65 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

e319fb3e-6294-49fb-8c59-a37d1ab85dd4
March 29, 2018
2
September 24, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
7816097829
support@respiratorymotion.com
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