FDA.reportPublic FDA data

GoWISE USA

Primary DI
20819687020294
Brand
GoWISE USA
Company
MING'S MARK INC.
Model
GW22041
Published
2017-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
false

Product Codes#

Code, Name table
CodeName
FRIScale, Stand-On, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRIScale, Stand-On, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819687020297PackageGS11In Commercial Distribution
20819687020294PackageGS11In Commercial Distribution
00819687020290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081968702029710819687020297
2081968702029420819687020294
00819687020290008196870202908196870202900819687020290

GMDN Terms#

Term, Definition table
TermDefinition
Stand-on floor scale, electronicAn electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005175432
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853821006030GoWISE USAGW220292016-08-23
00819687020115GoWISE USA GW220632017-07-26
00819687020290GoWISE USA GW220412017-12-29
00819687020306GoWISE USA GW220422017-12-29
00853113007028GoWISE USA GW220512016-12-06
00853821006368GoWISE USA GW220402017-03-12
20853113007022GoWISE USA GW220512016-12-06
00853821006023GoWISE USAGW220252016-08-23
00853821006047GoWISE USAGW220272016-08-23
20853821006362GoWISE USA GW220402017-03-12
00853821006825GoWISE USAGW220612016-08-23
20819687020119GoWISE USA GW220632017-07-26
20819687020300GoWISE USA GW220422017-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00850068074389TenoviTenovi Co.FRI2025-11-20
00850068074471TenoviTenovi Co.FRI2025-11-20
04719846016699CharderCHARDER ELECTRONIC CO., LTD.FRI2025-11-13
00850033352191Dario Smart Scale (Cellular)- Wight Management SystemDARIOHEALTH CORP.FRI2025-10-15
00810079260010Teladoc Health, Inc.Teladoc Health, Inc.FRI2025-09-22
00845717011785R.P.M. PROVERIDIAN HEALTHCARE LLCFRI2025-09-08
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04012030022682seca 284seca GmbH & Co. KGFRI2025-08-07
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00860013816506Empo FootprintEmpo Health, Inc.FRI2025-07-31
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04012030022637seca 264seca GmbH & Co. KGFRI2025-06-02
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B726BT007A0BodyTraceBODYTRACE, INCFRI2025-03-14
B726BT007B0BodyTraceBODYTRACE, INCFRI2025-03-14
B726BT007A1BodyTraceBODYTRACE, INCFRI2025-03-14
B726BT007B1BodyTraceBODYTRACE, INCFRI2025-03-14
06970729040080TeleRPM™Zhongshan Transtek Electronics Co.,LtdFRI2025-02-06
00850070979108FondCircleFondCircle Inc.FRI2025-01-14