FDA.reportPublic FDA data

JUMPER

Primary DI
06951740517898
Brand
JUMPER
Company
Shenzhen Jumper Medical Equipment Co.,Ltd.
Model
HWA11
Published
2023-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
K231310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231310000Electronic Blood Pressure MonitorShenzhen Jumper Medical Equipment Co., Ltd.2023-10-27DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06951740517898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06951740517898069517405178986951740517898

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529217911
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06951740500593JUMPERHWA202023-11-03
06951740517904JUMPERHWA212023-11-03
06951740500586JUMPERHWA102023-10-31
06951740504638JUMPERJPD-ES1002018-03-13
06951740540377THERMOBIOhttps://gudid.fda.gov/gudid/resources/images/icons2025-10-18
06951740540360NOVAPO-3012025-08-07
06951740518147JUMPERJPD-HA201C2025-05-09
06951740520188JUMPERJPD-100E12025-05-09
06951740500562JUMPERHAA102025-04-02
06951740500579JUMPERHAA202025-04-02
06951740517935JUMPERHAA212025-04-02
06951740517942JUMPERHAA112025-04-02
06951740540162JUMPERJPD-510E2024-07-17
06951740520171JUMPERJPD-100F2025-02-07
06951740550192JUMPERJPD-ES2302025-01-17
06951740550277JUMPERLPA112025-01-17
06951740540049pluse oximeterSPA102023-10-20
06951740540056pluse oximeterSPA112023-10-20
06951740540063pluse oximeterSPA202023-10-20
06951740540070pluse oximeterSPA302023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
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06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01
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