FDA.reportPublic FDA data

Health o meter professional

Primary DI
00851628008899
Brand
Health o meter professional
Company
Pelstar, LLC
Model
3400KG
Device description
Digital Diaper or Organ Scale
Published
2022-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FRWScale, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRWScale, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851628008899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851628008899008516280088998516280088990851628008899

GMDN Terms#

Term, Definition table
TermDefinition
Medical/surgical procedure scale, electronicAn electronic device designed to weigh body tissues and/or clinical objects [e.g., dressings, surgical sponges, nappies (diapers)] in association with a medical/surgical procedure and/or at autopsy. It is not intended to weigh a patient (including infants), and is not intended for laboratory use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037289290
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851628008813Health o meter professionalPTS-1000KL2022-11-22
00850017694279Health o meter professional51002022-11-16
00850017694286Health o meter professional52002022-11-16
00850017694293Health o meter professional53002022-11-16
00850017694309Health o meter professional54002022-11-16
00850017694316Health o meter professional54302022-11-16
00850017694323Health o meter professional55002022-11-16
00850017694330Health o meter professional59002022-11-16
00854896003535Health o meter professionalBABYSLINGSCALE2022-04-21
00850017694118Health o meter professional523KL2022-03-30
00850017694187Health o meter professional752KL-BT2022-03-30
00850017694194Health o meter professional752KG-BT2022-03-30
00850017694750Health o meter professional880KG2022-03-30
00851628008042Health o meter professional550KL2022-03-30
00851628008073Health o meter professional596KL2022-03-30
00851628008646Health o meter professional599KG2022-03-30
00851628008653Health o meter professional600KG2022-03-30
00851628008660Health o meter professional752KG2022-03-30
00851628008677Health o meter professional600KG-BT2022-03-30
00851628008752Health o meter professional844KL-C2022-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10688503002065SavariaSavaria Concord LiftFRW2026-07-20
10688503002072SavariaSavaria Concord LiftFRW2026-07-20
00849987000005SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000012SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000272SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000289SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000333SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000883SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987000890SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987001767SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987001774SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987001781SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987001798SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002320SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002344SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002771SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002788SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002818SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002825SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987002832SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
00849987003020SR ScalesS R INSTRUMENTS, INC.FRW2026-06-23
04012030022927seca 406seca GmbH & Co. KGFRW2026-04-22
H933P11634Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FRW2025-12-03
04719846015753CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
04719846016040CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
40080196291237MEDLINEMEDLINE INDUSTRIES, INC.FRW2025-06-25
00860012873609WoddleWoddle Baby, Inc.FRW2025-06-02
10688503001051SavariaSavaria Concord LiftFRW2025-05-29
10688503001068SavariaSavaria Concord LiftFRW2025-05-29
00628725008264Smart ScaleCanadian Hospital Specialties LimitedFRW2025-02-28