FDA.reportPublic FDA data

Telemetry Transmitter

Primary DI
06944413802278
Brand
Telemetry Transmitter
Company
Edan Instruments, Inc.
Model
iT20
Published
2017-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161056000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161056000Telemetry TransmitterEdan Instruments, Inc.2017-02-03MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06944413802278PackageGS14In Commercial Distribution
06944413802261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06944413802278069444138022786944413802278
06944413802261069444138022616944413802261

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529173163
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06944413805323SpO2 SensorSpO2 Finger Sensor, adult, 1m, reusable2016-09-01
06944413805361SpO2 SensorSH4 Adult Silicone Soft-tip2016-09-01
06944413805385SpO2 SensorSH5 pediatric Silicone Soft-tip2016-09-01
06944413805422SpO2 SensorSHD-P, pediatric, disposable2016-09-01
06944413805439SpO2 SensorSHD-A , adult, disposable2016-09-01
06944413807075iT20 SpO2 extension cableiT20 SpO2 extension cable, 0.65m2017-02-22
06944413809468Connection Cable01.13.0374772026-10-15
06944413835153Telemetry MonitoriT302026-08-26
06944413835214Telemetry MonitoriT502026-08-26
06944413844919SE-1202 Series ElectrocardiographSE-1202E2026-07-21
06944413847422SE-1202 Series ElectrocardiographSE-12022026-07-21
06944413817210Connection Cable01.57.4721782026-05-19
06944413817234 Connection Cable01.57.4722162026-05-19
06944413820050EMG/Stimulation sensor01.57.4726242026-05-19
06944413820074EMG/Stimulation sensor01.57.4726312026-05-19
06944413825475Connection Cable01.57.4722812026-05-19
06944413825482Connection Cable01.57.4723812026-05-19
06944413834026EMG/Stimulation sensor01.57.4726252026-05-19
06944413834736EMG/Stimulation sensor01.57.472623 2026-05-19
06944413866133Stimulation SystemPR362026-05-15

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Primary DI, Brand, Company table
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B353UB25511UbiqVue MultiparameterLifesignals, Inc.DRG2026-07-20
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2026-06-02
04719875011016EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011023EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
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B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10