FDA.reportPublic FDA data

G.LAB

Primary DI
04895045403666
Brand
G.LAB
Company
Grandway Technology (Shenzhen) Limited
Model
MD3150
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K152483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152483000Digital Automatic Blood Pressure Monitor BPM30 and BPM31 SeriesGrandway Technology (Shenzhen) Limited2015-09-29DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04895045403666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04895045403666048950454036664895045403666

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
420764247
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04895045403611G.LABMD20102017-02-13
04895045404021G.LABMD59402021-05-05
08534550072122G.LABMD54702021-01-25
04895045403819BelifuMD31512020-08-19
04895045403598G.LABMD11802017-02-13
04895045403604G.LABMD15202017-02-13
04895045403628G.LABMD22002017-02-13
04895045403635G.LABMD22222017-02-13
04895045403642G.LABMD22312017-02-13
04895045403659G.LABMD25802017-02-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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