FDA.report

NA

Primary DI
00841983100123
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
BM-001B
Catalog number
BM-001B
Device description
Extension Cable For NM-317Y3 NCS electrode, with 6 pin connector
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

Related Records

Contact Domains

Product Codes

CodeName
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE

Product Code Classifications

CodeDeviceSpecialtyClass
GWFStimulator, Electrical, Evoked ResponseNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841983100123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983100123008419831001238419831001230841983100123

GMDN Terms

TermDefinition
Evoked-potential graphic recording systemAn assembly of devices designed for recording a localized electrical potential from the brain or spinal cord in response to stimulation (i.e., visual, auditory, and/or somatosensory) of the sensory organs, or of some point along the ascending pathway from the sensory organs, or within the central nervous system. It typically includes a sensory stimulator/stimulation system and a graphic recorder. The characteristics of the recorded potential vary with recording location, stimulus modality and level, and level of consciousness or anaesthesia. The resultant waveform may be used to assess the function and integrity of the brain and its sensory pathways.

Sterilization Methods

Method

Contacts

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 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 DIBrandCompanyProduct codePublished
00190376509747SafeOp 3ALPHATEC SPINE, INC.GWF2026-03-24
00382830051910NatusNATUS NEUROLOGY INCORPORATEDGWF2026-02-18
00810155862589NONENeurovision Medical Products, Inc.GWF2025-12-19
00810155862602NONENeurovision Medical Products, Inc.GWF2025-12-19
00810155862626NONENeurovision Medical Products, Inc.GWF2025-12-19
00810155862640NONENeurovision Medical Products, Inc.GWF2025-12-19
B006NVHS1021NONENeurovision Medical Products, Inc.GWF2025-12-18
04250307611959N/Ainomed Medizintechnik GmbHGWF2025-05-02
06430063200187Nexstim NBS SystemNEXSTIM, INC.GWF2025-04-01
05060229530868Magstim Double 70mm Air Film CoilTHE MAGSTIM COMPANY LIMITEDGWF2025-02-19
B006NVPS2Nerveäna+®NEUROVISION MEDICAL PRODUCTS, INC.GWF2025-02-11
00382830032759NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830032872NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830034357NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830034395NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830035002NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830035019NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830035026NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830035033NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830036153NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830036160NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830044998NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830045070NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830045087NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830046916NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830046930NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830046947NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830051385NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830053082NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06
00382830059374NatusNATUS NEUROLOGY INCORPORATEDGWF2025-02-06