FDA.report

NA

Primary DI
04931921867686
Brand
NA
Company
NIHON KOHDEN CORPORATION
Model
BR-916PA
Catalog number
BR-916PA
Device description
Electrode lead, 6 electrodes (AHA) (Snap type)
Published
2016-09-05
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

Related Records

Contact Domains

Product Codes

CodeName
DRTMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)

Product Code Classifications

CodeDeviceSpecialtyClass
DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04931921867686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04931921867686049319218676864931921867686

GMDN Terms

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

Contacts

PhoneEmail
+1(800)325-0283info@nkusa.com

Regulatory Flags

DUNS number
690568050
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

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