FDA.reportPublic FDA data

ExSpiron 1Xi

Primary DI
00851540007024
Brand
ExSpiron 1Xi
Company
Respiratory Motion Inc.
Model
Power Cord, 10'
Catalog number
RMI-51250
Device description
Insulated, reusable, medical grade electrical cord design to enable connection of the ExSpiron 1Xi to a mains electricity supply socket, with a NEMA 5-15P plug and an IEC 60320-C13 connector at either end.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZKSpirometer, Monitoring (W/Wo Alarm)
BZQMonitor, Breathing Frequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2
BZQMonitor, Breathing FrequencyAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130170000EXSPIRON 1XIRespiratory Motion, Inc.2013-05-29BZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851540007109PackageGS11In Commercial Distribution
00851540007024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851540007109008515400071098515400071090851540007109
00851540007024008515400070248515400070240851540007024

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7816097829support@respiratorymotion.com
2399204288info.us@senzime.com
800-213-1324info.us@senzime.com

Regulatory Flags#

DUNS number
963613745
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851540007000ExSpiron 1XiMonitorRMI-510002016-09-24
00851540007017ExSpiron Patient Cable, 8'RMI-511302016-09-24
00851540007055ExSpiron 1XiNurse Call ModuleRMI-511552016-09-24

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Primary DI, Brand, Company table
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10889483610565Resmed Sleep Apnealink CannulaSALTER LABSBZQ2025-07-11
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G2331000000SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000010SansaTMHuxley Medical, Inc.BZQ2024-10-21
G2331000020SansaTMHuxley Medical, Inc.BZQ2024-10-21
10843997006184Radius VSMMASIMO CORPORATIONBZQ2024-08-19
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2024-06-19
00195278656681Portrait CVAXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278659446Portrait CSSXBGE Medical Systems Information Technologies, Inc.BZQ2024-04-30
00195278697165PORTRAIT HSWXBGE Healthcare Finland OyBZQ2024-04-30
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00195278699916PORTRAIT AAB01GE Healthcare Finland OyBZQ2023-10-26
00195278120014PORTRAIT SBT01GE Healthcare Finland OyBZQ2023-09-12
00195278223401PORTRAIT RRP01GE Healthcare Finland OyBZQ2023-09-12
00195278093998PORTRAIT HUB01GE Healthcare Finland OyBZQ2023-09-01
00195278094001PORTRAIT BCH01GE Healthcare Finland OyBZQ2023-09-01
00195278110435PORTRAIT MMP01GE Healthcare Finland OyBZQ2023-09-01
00195278201980PORTRAIT AAB01GE Healthcare Finland OyBZQ2023-09-01
00195278264794PORTRAIT SpO2 P-SP01GE Healthcare Finland OyBZQ2023-09-01
00195278264800PORTRAIT SpO2 P-W01GE Healthcare Finland OyBZQ2023-09-01
00195278264817PORTRAIT RR P-RR01GE Healthcare Finland OyBZQ2023-09-01
00195278264831PORTRAIT SpO2 P-SA01GE Healthcare Finland OyBZQ2023-09-01
00195278330413Portrait CVA01GE Medical Systems Information Technologies, Inc.BZQ2023-09-01