FDA.reportPublic FDA data

ExSpiron PadSets

Primary DI
00851540007048
Brand
ExSpiron PadSets
Company
Senzime AB (Publ.)
Model
Adult
Catalog number
RMI-51110
Device description
A non-sterile, single use electrode set designed to be adhered across a patient's chest and connected to the ExSpiron Monitor for impedance pneumography. Consists of electrodes and lead wire to allow for impedance measurements across a chest cavity.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
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
00851540007116PackageGS125In Commercial Distribution
10851540007113PackageGS11In Commercial Distribution
20851540007042PackageGS1100In Commercial Distribution
20851540007110PackageGS12In Commercial Distribution
30851540007117PackageGS14In Commercial Distribution
00851540007048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851540007116008515400071168515400071160851540007116
1085154000711310851540007113
2085154000704220851540007042
2085154000711020851540007110
3085154000711730851540007117
00851540007048008515400070488515400070480851540007048

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeA non-sterile, electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius32 Degrees Celsius
Handling Environment Temperature10 Degrees Celsius27 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius27 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
559976316
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350012440268TetraHubSEN 2017SEN 20172024-10-11
07350012440237TetraGraphSEN 2015 TetraGraph monitorSEN 20152024-10-03
07350012440022TetraSensTetraSensSEN 20022020-04-23
07350012440121TetraSens PediatricSEN 2009 TetraSens PediatricSEN 20092022-09-07
07350012440169TetraSensSEN 2012 TetraSensSEN 20122024-04-26
07350012440183TetraSens PediatricSEN 2013 TetraSens PediatricSEN 20132024-04-26
07350012440244TetraSensitiveSEN 2016 TetraSensitiveSEN 20162024-04-26
00851540007161ExSpiron Pediatric PadSetsPediatricRMI-530402024-01-25
07350012440206TetraSensitiveSEN 2014 TetraSensitiveSEN 20142023-11-06
07350012440107TetraGraph Philips InterfaceTetraGraph Philips InterfaceSEN 20072022-09-07
07350012440145TetraGraph XcomSEN 2010 TetraGraph XcomSEN 20102022-09-07
07350012440015TetraGraphSEN 2001 TetraGraph monitorSEN 20012020-04-23
07350012440091TetraGraph Pole Clamp kitSEN 2101 Pole Clamp for TetraGraph (Optional)SEN 21012020-04-23
00851540007147ExSpiron 2XiRMI-540002020-01-06
07350012440176TetraSensSEN 2012 TetraSensSEN 20122024-04-26
07350012440190TetraSens PediatricSEN 2013 TetraSens PediatricSEN 20132024-04-26
07350012440251TetraSensitiveSEN 2016 TetraSensitiveSEN 20162024-04-26
07350012440114TetraSens PediatricSEN 2009 TetraSens PediatricSEN 20092022-09-07
07350012440039TetraSensTetraSensSEN 20022020-04-23

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Primary DI, Brand, Company table
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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
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