FDA.reportPublic FDA data

SunTech Medical

Primary DI
10840935110002
Brand
SunTech Medical
Company
SUNTECH MEDICAL, INC.
Model
99-0240-00
Published
2022-12-14
Public version status
New
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
K160439000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160439000SunTech CT40 Spot-check Vital Signs DeviceSuntech Medical2016-07-06DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840935110002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084093511000210840935110002

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check system, clinicalAn electrically-powered device assembly designed for professional use in a clinical setting to spot-check (user-initiated) measure and display multiple patient physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2), blood glucose]; it has no continuous monitoring capability or programmable alarm features. It typically includes a main analysis unit with a visual display and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, SpO2 probe, spirometer), and potentially in vitro diagnostic [IVD] analysers (e.g., clinical chemistry analyser, urine analyser).

Contacts#

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

Regulatory Flags#

DUNS number
148191133
Device count
1
Serial number
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
08800096401772Auto Blood Pressure MeterSEERS.Co.,LtdDXN2026-05-13
10850047516036KismeTruth Remote Patient MonitoringRemote Smart Health, LLCDXN2026-03-26
10840935111580Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111597Adult Plus Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
10840935111603Large Adult Orbit-K Cuff with Microphone, Bayonet, Reverse OrientationSUNTECH MEDICAL, INC.DXN2025-09-10
08690020003017VitalScan ANSMedeia, Inc.DXN2025-02-05
10884450360634Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2024-09-06
09120073933027CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXN2024-07-10
08720256776529Corsano CardioWatch 287-2 SystemCorsano Health B.V.DXN2024-06-19
10884450388164Merit Medical®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2023-03-03
09120073932990CNAP® Monitor 500 HDCNSystems Medizintechnik GmbHDXN2022-06-09
10884450385163Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-06-08
10884450323264Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-03-04
10884450619282Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450619299Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450621155Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-28
10884450371777Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2022-02-18
10884450371739Meritrans DTXPlus®ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-10-12
10884450372781Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-07-21
10840935109662Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
10840935109679Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
10840935109686Oscar 2SUNTECH MEDICAL, INC.DXN2021-04-09
G057IDBP8080IDEA HealthIDEA HEALTH LLCDXN2021-04-08
10884450544157Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DXN2021-01-27
10193489012903MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012927MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012965MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-16
10193489012934MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-14
10193489012972MedlineMEDLINE INDUSTRIES, INC.DXN2020-12-14
10840935109396SunTechSUNTECH MEDICAL, INC.DXN2020-11-19