FDA.reportPublic FDA data

WowGoHealth Control Solution - GSH-BGM902 - Level 1

Primary DI
04719878121156
Brand
WowGoHealth Control Solution - GSH-BGM902 - Level 1
Company
GOLDEN SMART HOME TECHNOLOGY CORP.
Model
GSH-BGM902 - Level 1
Device description
The WowGoHealth Control Solution should be tested on WowGoHealth meter using WowGoHealth test strips to make sure the meter and test strips are working properly.
Published
2019-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878121156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878121156047198781211564719878121156

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+88635770693service@goldensmarthome.com.tw

Regulatory Flags#

DUNS number
656002163
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719878121125WowGoHealth Blood Glucose Test Strips - GSH-BGM902 - 2*25GSH-BGM902 - 2*252019-07-04
04719878123518WowGoHealth Infrared Ear & Forehead Thermometer GSH-351GSH-3512023-03-28
04719878124027WowGoHealth Pulse Oximeter GSH601GSH601Orange2021-01-26
04719878124010WowGoHealth Pulse Oximeter GSH601GSH601Gray2020-07-09
04719878122313WowGoHealth Bluetooth Body Fat AnalyzerGSH231 (A3K)2021-05-24
14719878122310WowGoHealth Bluetooth Body Fat AnalyzerGSH231 (A3K)2021-05-24
04719878120036WowGoHealth Automatic Arm Bluetooth Blood Pressure MonitorGSH8622020-08-07
34719878120037WowGoHealth Automatic Arm Bluetooth Blood Pressure MonitorGSH8622020-08-07
04719878122023WowGoHealth Body Fat Analyzer GSH202-BGSH202-B2020-04-19
14719878122020WowGoHealth Body Fat Analyzer GSH202-BGSH202-B2020-04-19
04719878120029WowGoHealth Blood Pressure Monitor GSH885BGSH885B2019-05-17
34719878120020WowGoHealth Blood Pressure Monitor GSH885BGSH885B2019-05-17
04719878120012WowGoHealthBlood Pressure Monitor LS802-B2019-04-18
04719878123013WowGoHealth IR Ear Thermometer with Bluetooth GSH-BTS301GSH-BTS3012019-07-12
04719878121019WowGoHealth Blood Glucose Monitoring System GSH-BGM902GSH-BGM9022019-07-04

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Primary DI, Brand, Company table
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30732671309403PipAMITY HOLDINGS, LLCJJX2026-04-16
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00021292015398TRUE METRIXTRIVIDIA HEALTH, INC.JJX2025-10-02
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00021292008420TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008437TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008444TRUE FOCUSTRIVIDIA HEALTH, INC.JJX2021-02-26
00021292008369TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
00021292008383TRUEcontrolTRIVIDIA HEALTH, INC.JJX2021-01-29
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00021292008390TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21
00021292008406TRUE METRIXTRIVIDIA HEALTH, INC.JJX2020-10-21