FDA.reportPublic FDA data

ExSpiron

Primary DI
00851540007017
Brand
ExSpiron
Company
Respiratory Motion Inc.
Model
Patient Cable, 8'
Catalog number
RMI-51130
Device description
Noninvasive, insulated, electrical cable designed to connect the ExSpiron Monitor to the ExSpiron PadSet.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

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
00851540007093PackageGS11In Commercial Distribution
00851540007017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851540007093008515400070938515400070930851540007093
00851540007017008515400070178515400070170851540007017

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA 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.

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
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851540007000ExSpiron 1XiMonitorRMI-510002016-09-24
00851540007024ExSpiron 1XiPower Cord, 10'RMI-512502016-09-24
00851540007055ExSpiron 1XiNurse Call ModuleRMI-511552016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.BZQ2026-06-02
20653405024962CONMEDConmed CorporationBZQ2026-03-24
10889483224366MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
10889483225295MVAP Comfort Sleep Nasal CannulaSALTER LABSBZQ2026-03-13
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.BZQ2025-12-10
07640121881053103583 LuMon™ Contact Gel KitSenTec AGBZQ2025-09-08
10889483610565Resmed Sleep Apnealink CannulaSALTER LABSBZQ2025-07-11
20860006382302SENSINEL™ CPM REPLACEMENT ADHESIVES (15 Pack)Analog Devices, Inc.BZQ2025-03-13
17290020154009BB-613P Chest-Monitor 40-Unit MultipackBIOBEAT TECHNOLOGIES LTDBZQ2025-03-05
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
00195278713193Portrait HUBXBGE Healthcare Finland OyBZQ2024-04-30
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