FDA.reportPublic FDA data

Bionet

Primary DI
10840935109228
Brand
Bionet
Company
SUNTECH MEDICAL, INC.
Model
98-0036-04
Published
2020-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151520000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151520000Oscar 2Suntech Medical, Inc.2016-02-19DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840935109228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084093510922810840935109228

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-919-654-2300UDI_Mail@suntechmed.com

Regulatory Flags#

DUNS number
148191133
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840935111702Straight Black Hose, Female Bayonet to Female Bayonet, 9.8ft (3m), Siemens91-0032-332025-12-01
10840935111719Straight Gray Hose, Female Luer to Female Bayonet, 9.8ft (3m), Siemens91-0032-342025-12-01
10840935111696Patient Hose91-0028-232025-11-18
10840935111580Adult Orbit-K Cuff with Microphone, Bayonet, Reverse Orientation98-0062-392025-09-10
10840935111597Adult Plus Orbit-K Cuff with Microphone, Bayonet, Reverse Orientation98-0062-402025-09-10
10840935111603Large Adult Orbit-K Cuff with Microphone, Bayonet, Reverse Orientation98-0062-412025-09-10
10840935110507Patient Hose, 1.2 meter Bayonet, Black, RDT91-0028-322025-07-29
10840935110514Patient Hose, 8 feet, with Female Bayonet Connect and Male Inline Right Angle Pu91-0028-802025-07-29
10840935110521Straight Black Hose, Female Bayonet to Male Inline Right Angle Connector, 10ft (91-0028-982025-07-29
10840935107552Disposable Cuff98-0699-042017-05-25
10840935107569Disposable cuff98-0699-052017-05-25
10840935107576Disposable cuff98-0399-C02017-05-25
10840935107583Disposable Cuff98-0399-C12017-05-25
10840935107606Disposable cuff98-0399-C32017-05-25
10840935107620Disposable cuff98-0399-C52017-05-25
10840935107637disposable cuff98-0399-C62017-05-25
10840935107644Disposable Cuff98-0399-C72017-05-25
10840935107651Disposable cuff98-0399-C82017-05-25
10840935107668Disposable cuff98-0399-C92017-05-25
10840935108085Disposable Cuff98-0399-3K2018-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01