FDA.reportPublic FDA data

NA

Primary DI
00841983102226
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
BR-202DA
Catalog number
BR-202DA
Device description
Electrode lead for 12 lead, AHA tip
Published
2016-09-19
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DPSELECTROCARDIOGRAPH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841983102226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983102226008419831022268419831022260841983102226

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
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
10841983103947NAA/PA-9000ZA/PA-9000Z2016-09-24
10841983103954NAA/PA-9100ZA/PA-9100Z2016-09-24
10841983103930NAA/PA-1550ZA/PA-1550Z2016-09-24
00841983104336NK-HealthProtect Wireless Surge SolutionA-WSS-002-ZAA-WSS-002-ZA2021-12-23
10841983102667NATL-052STL-052S2016-09-19
10841983102674NATL-062STL-062S2016-09-19
10841983102704BluPRO®TL-271TTL-271T2016-09-19
10841983102711BluPRO®TL-271T3TL-271T32016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809276943958Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276943965Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276943972Cardio P1Bionet CO,LTDDPS2026-05-26
08809276944269Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276944276Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
00884838117358patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-05
00884838117273patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117280patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117297patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117303patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117310patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117327patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117334patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117341patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00843997011006Radius VSMMASIMO CORPORATIONDPS2026-02-23
00843997016018Radius VSMMASIMO CORPORATIONDPS2026-02-23
00884838131958Cardiologs PlatformPHILIPS FRANCEDPS2026-02-16
00732094360363Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-02-03
00732094360370Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-02-03
G697100010010CloudHRV™ SystemInmedix, Inc.DPS2026-01-30
00198953107263MACGe Medical Systems Information Technologies, Inc.DPS2026-01-27
00884838117198patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117204patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117211patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117228patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117259patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15
00884838117266patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15
00884838117235patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2025-12-15
00884838117242patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2025-12-15
00732094237740Welch Allyn, Inc.WELCH ALLYN, INC.DPS2025-09-22