FDA.report

NA

Primary DI
00841983103193
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
BSM-4114A
Catalog number
BSM-4114A
Device description
PATIENT MONITOR, without RECORDER
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications

CodeDeviceSpecialtyClass
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841983103193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983103193008419831031938419831031930841983103193

GMDN Terms

TermDefinition
Patient monitoring system central station monitorA mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].

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
false
Serial number
true
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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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
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10841983102667NATL-052STL-052S2016-09-19
10841983102674NATL-062STL-062S2016-09-19
10841983102704BluPRO®TL-271TTL-271T2016-09-19
10841983102711BluPRO®TL-271T3TL-271T32016-09-19

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