FDA.reportPublic FDA data

NA

Primary DI
00841983102554
Brand
NA
Company
NIHON KOHDEN AMERICA, INC.
Model
ORG-9100A
Catalog number
ORG-9100A
Device description
WMTS digital telemetry receiver; 608 UHF MHz
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
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841983102554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841983102554008419831025548419831025540841983102554

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring system receiverA mains electricity (AC-powered) component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).

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
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

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

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10884521858657Vital SyncCovidien LPDRG2026-01-16
00850064210309ANNE Chest Adhesive - Gentle Wear Shelf BoxSibel Health Inc.DRG2025-12-17
10884521856127Vital SyncCovidien LPDRG2025-09-01
10884521856134Vital SyncCovidien LPDRG2025-08-18
10884521851559Vital SyncCovidien LPDRG2025-04-27
B353UA2251C1UbiqVue Lifesignals, Inc.DRG2025-04-22
B353UA2251S1UbiqVue Lifesignals, Inc.DRG2025-04-22
B353UA2251W1UbiqVue Lifesignals, Inc.DRG2025-04-22
B353UB12512UbiqVue HolterLifesignals, Inc.DRG2025-04-22
B353UB22512UbiqVue HolterLifesignals, Inc.DRG2025-04-22
00850064210200Sibel Spacelabs Trek Chest PatchSibel Health Inc.DRG2025-04-02
00850064210248Sibel Spacelabs Trek Chest Patch AdhesiveSibel Health Inc.DRG2025-04-02
00850064210255Sibel Spacelabs Trek Blood Pressure CuffSibel Health Inc.DRG2025-04-02
00850064210002ANNE Chest Sensor KitSibel Health Inc.DRG2025-03-26
008500642100197-Day ANNE Chest Adhesive PouchSibel Health Inc.DRG2025-03-26
008500642100261-Day ANNE Chest Adhesive PouchSibel Health Inc.DRG2025-03-26
008500642101017-Day ANNE Chest Adhesive Shelf BoxSibel Health Inc.DRG2025-03-26
00850064210132ANNE View Patient MonitorSibel Health Inc.DRG2025-03-26
00850064210149ANNE Chest SensorSibel Health Inc.DRG2025-03-26
00850005949466BioDashboardBIOINTELLISENSE, INC.DRG2025-02-28
08056732652422HD+12CARDIOLINE SPADRG2025-02-26
08056732652712PATIENT CABLE SNAP 10 WIRES IEC FOR HD+ ORANGECARDIOLINE SPADRG2025-02-26
08056732652736PATIENT CABLE PLUG 10 WIRES AHA FOR HD+ ORANGECARDIOLINE SPADRG2025-02-26
10850005949555BioButton (Reprocessed)BIOINTELLISENSE, INC.DRG2025-02-19
10850005949562BioButton (Reprocessed, NF Version)BIOINTELLISENSE, INC.DRG2025-02-19
10850005949593BioButton Charging StationBIOINTELLISENSE, INC.DRG2025-02-19
10850005949449BioButton Rechargeable Device, Multi-PatientBIOINTELLISENSE, INC.DRG2025-02-11
10884521854260Vital SyncCovidien LPDRG2024-12-27