FDA.reportPublic FDA data

Greater Goods

Primary DI
00875011006484
Brand
Greater Goods
Company
Greater Goods
Model
0648
Device description
BPM w/ XL soft cuff
Published
2023-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K200521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200521000Full Automatic(NIBP) Blood Pressure MonitorHealth & Life Co., Ltd.2020-06-12DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10875011006481PackageGS16In Commercial Distribution
00875011006484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1087501100648110875011006481
00875011006484008750110064848750110064840875011006484

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length56Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8669918494info@greatergoods.com

Regulatory Flags#

DUNS number
189583599
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00875011000406Greater Goods 00402025-06-09
10875011000403Greater Goods 00402025-06-09
00875011000116Greater Goods 00112025-04-20
00875011000123Greater Goods 00122025-04-20
10875011000113Greater Goods 00112025-04-20
10875011000120Greater Goods 00122025-04-20
00875011006675Greater Goods 06672025-02-12
00875011006927Greater Goods 06922025-02-12
00875011006934Greater Goods 06932025-02-12
00875011006941Greater Goods 06942025-02-12
00875011006613Greater Goods 06612025-02-12
10875011006672Greater Goods 06672025-02-12
10875011006924Greater Goods 06922025-02-12
10875011006931Greater Goods 06932025-02-12
10875011006948Greater Goods 06942025-02-12
00875011006699Greater Goods06692024-11-24
00875011006682Greater Goods06682024-11-24
10875011006696Greater Goods06692024-11-24
00875011006125Greater Goods06122020-08-31
00875011006149Greater Goods06142020-11-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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