FDA.reportPublic FDA data

NA

Primary DI
00841983100154
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
BR-903PA
Catalog number
BR-903PA
Device description
ECG Electrode Lead (3 Electrodes) AHA, clip type
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011918000NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIESNihon Kohden America, Inc.2001-09-12MHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841983100154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983100154008419831001548419831001540841983100154

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)325-0283info@nkusa.com

Regulatory Flags#

DUNS number
021063219
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841983101493NAYG-101TYG-101T2016-09-19
10841983101509NAYG-111TYG-111T2016-09-19
10841983101516cap-ONEYG-122TYG-122T2016-09-19
10841983101523NAYG-211TYG-211T2016-09-19
10841983101530NAYG-213TYG-213T2016-09-19
10841983101547NAYG-214TYG-214T2016-09-19
10841983101554cap-ONEYG-232TYG-232T2016-09-19
10841983101561cap-ONEYG-242TYG-242T2016-09-19
10841983102766cap-ONEYG-125TYG-125T2016-09-19
10841983102773cap-ONEYG-135TYG-135T2016-09-19
10841983102780cap-ONEYG-225TYG-225T2016-09-19
10841983102797cap-ONEYG-235TYG-235T2016-09-19
00841983100673NAJG-900PJG-900P2016-09-19
00841983101434NATG-101TTG-101T2016-09-19
00841983102295NAOLG-2800AOLG-2800A2016-09-19
00841983102622NATG-900PTG-900P2016-09-19
00841983102639cap-ONETG-920PTG-920P2016-09-19
00841983102646cap-ONETG-921T3TG-921T32016-09-19
00841983102653cap-ONETG-970PTG-970P2016-09-19
10841983101592NAYG-921PYG-921P2016-09-19

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04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
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00884838119048Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119055Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119062Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119185Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119192Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119208Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119215Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
00884838119222Telemetry AccessoriesPhilips Medizin Systeme Böblingen GmbHMHX2026-05-28
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