FDA.reportPublic FDA data

seca mVSA 535

Primary DI
04012030019125
Brand
seca mVSA 535
Company
seca GmbH & Co. KG
Model
535
Catalog number
5351010131
Device description
Spot-check-monitor inclusive blood pressure and FILAC temperature module.
Published
2020-02-28
Public version status
Update
Distribution status
Not 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
FLLThermometer, electronic, clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192092000Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535Seca GmbH & Co. KG2020-01-23DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04012030019125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04012030019125040120300191254012030019125

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check analysis system, clinicalAn electrically-powered device assembly, possibly with a rechargeable battery, designed to electronically measure and display multiple patient physiological parameters [e.g., noninvasive blood pressure (NIBP), pulse rate, temperature, and haemoglobin oxygen saturation (SpO2)] for intermittent spot-check measuring by a healthcare professional; 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). It may be attached to a wheeled stand or wall-mounted.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)5427322info.us@seca.com

Regulatory Flags#

DUNS number
316584937
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04012030026963seca 65065065013210042026-10-01
04012030026987seca 65465465413210042026-10-01
04012030024921seca analytics 12512512520000402026-06-02
04012030022927seca 40640640600000092026-04-22
04012030020053seca 78778778718210092019-08-31
04012030021531seca 62062062034000092025-11-01
04012030022774seca 28628628613000042025-08-08
04012030022682seca 28428428410001042025-08-07
04012030022699seca 28428428413001042025-08-07
04012030022705seca 28428428413101042025-08-07
04012030022637seca 26426426419000042025-06-02
04012030022668seca 27427427419000042025-06-02
04012030022026seca mBCA 54554554500170092025-05-01
04012030022033seca mBCA 54254254200090092025-05-01
04012030022910seca analytics 12512512520000302025-04-30
04012030021678seca analytics 12512512520000202023-10-12
04012030020503seca analytics 12512512520000102020-10-09
04012030020404seca 33333333310210092020-02-28
04012030008587seca 95495495413090072018-08-15
04012030015820seca 28628628615000092018-08-15

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850070979405FondCircleFondCircle Inc.DXN2026-10-21
00850070979412FondCircleFondCircle Inc.DXN2026-10-21
08719327007136FinapresFinapres Medical Systems B.V.DXN2026-10-21
09120095900809SteadyTempSteadySense GmbHFLL2026-10-21
06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
06974560230655ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-14
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
06974560230648ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-13
00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
06933257920187Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257926066YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
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06933257947023Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
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