FDA.reportPublic FDA data

RespArray quick start kit(AHA01)

Primary DI
06944413824713
Brand
RespArray quick start kit(AHA01)
Company
Edan Instruments, Inc.
Model
02.01.217622
Published
2022-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSACable, Transducer And Electrode, Patient, (Including Connector)
DXQBlood Pressure Cuff
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2
DXQBlood Pressure CuffCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220308000
K240320000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220308000Patient Monitor: RespArrayEdan Instruments, Inc.2022-08-11MHX
K240320000Patient Monitor (RespArray)Edan Instruments, Inc.2024-06-28MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16944413824710PackageGS14In Commercial Distribution
06944413824713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694441382471016944413824710
06944413824713069444138247136944413824713

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic lead set, reusableA collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529173163
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-10-28
00860016681507UNIVERHEALTHHangzhou Universal Electronic Co.,Ltd.FLL2026-10-28
04719872982296QT ECGQt Medical, Inc.DSA2026-10-28
04719872982302QT ECGQt Medical, Inc.DSA2026-10-28
04719872982418QT ECGQt Medical, Inc.DSA2026-10-28
06946725572924APKAPK Technology Co.,Ltd.DSA2026-10-26
00884838085299Dual IBP AdapterPhilips Medizin Systeme Böblingen GmbHDSA2026-10-21
09120095900809SteadyTempSteadySense GmbHFLL2026-10-21
G662ME361G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
G662ME368G1MaguireMaguire Enterprises, Inc.DSA2026-10-21
09120095900281SteadyTempSteadySense GmbHFLL2024-07-15
20192253008347CARDINAL HEALTHCardinal Health 200, LLCFLL2020-09-24
06940211627693MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627709MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211627969MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628010MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628027MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628034MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628041MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628058MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628065MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628089MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628096MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628102MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628126MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628133MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628140MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628157MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628164MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31
06940211628188MDF®MDF Instruments Medifriend Inc.DXQ2018-12-31