FDA.reportPublic FDA data

Withings®

Primary DI
13700546707336
Brand
Withings®
Company
WITHINGS
Model
WBS09-white
Published
2021-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
13700546707336PackageGS14In Commercial Distribution
03700546707339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1370054670733613700546707336
03700546707339037005467073393700546707339

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
260119720
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
false
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
03700546709937Withings®SCT02SCT02-032025-11-30
13700546709934Withings®SCT02SCT02-032025-11-30
03700546710209Withings®SCT02SCT02-022025-11-30
03700546708497Withings®WSM022024-10-03
13700546708494Withings®WSM022024-10-03
03700546708664Withings®WBS14-Black2024-02-14
13700546708661Withings®WBS14-Black2024-02-14
03700546708725Withings®WBS13-Olympics2023-10-05
13700546708722Withings®WBS13-Olympics2023-10-05
03700546708275Withings®HWA102023-09-07
13700546708272Withings®HWA102023-09-07
03700546708435Withings®WBS08-Black2023-08-30
03700546708442Withings®WBS08-White2023-08-30
13700546708432Withings®WBS08-Black2023-08-30
13700546708449Withings®WBS08-White2023-08-30
03700546708244Withings®WBS12C-White2023-08-28
03700546708237Withings®WBS12C-Black2023-06-08
13700546708234Withings®WBS12C-Black2023-06-08
03700546708190Withings®WBS13-Black2023-04-17
03700546708206Withings®WBS13-White2023-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849987003761SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003778SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003785SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003792SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003808SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003815SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003822SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987003839SR ScalesS R INSTRUMENTS, INC.FRI2026-06-26
00849987000029SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000036SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000135SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000142SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000159SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000166SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000173SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000180SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000197SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000203SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000210SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000258SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000265SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000449SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000777SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000784SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000791SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987000807SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001033SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001040SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001057SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23
00849987001064SR ScalesS R INSTRUMENTS, INC.FRI2026-06-23