FDA.report

Health o meter professional

Primary DI
00854896003993
Brand
Health o meter professional
Company
Pelstar, LLC
Model
553KG
Device description
Digital Baby Scale KG
Published
2022-03-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FRWScale, Patient

Product Code Classifications

CodeDeviceSpecialtyClass
FRWScale, PatientGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00854896003993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00854896003993008548960039938548960039930854896003993

GMDN Terms

TermDefinition
Infant scale, electronicAn electrically-powered device designed to measure the weight of an infant, particularly a newborn, or to monitor weight changes, e.g., during critical care procedures. It typically consist of a weight tray, a flexure plate or bending beam, an electronic transducer, and an analogue or digital display; it may include markings to also measure infant length. The device is also known as paediatric or baby scale.

Sterilization Methods

Method

Regulatory Flags

DUNS number
037289290
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
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 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

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04719846015753CharderCHARDER ELECTRONIC CO., LTD.FRW2025-08-07
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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
00628725008271SMART SCALECanadian Hospital Specialties LimitedFRW2025-02-28
00093764604454A&D MedicalA&D COMPANY, LIMITEDFRW2024-10-16
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14012030003756seca 212seca GmbH & Co. KGFRW2024-10-01
24012030004385seca 206seca GmbH & Co. KGFRW2024-10-01
14012030007259seca 201seca GmbH & Co. KGFRW2024-10-01
24012030007263seca 201seca GmbH & Co. KGFRW2024-10-01
05600494138736WUNDER RS300 PATIENT SCALE BIRDIE EVO XPLUSINVACARE CORPORATIONFRW2024-08-15
00732094251050Welch Allyn, Inc.WELCH ALLYN, INC.FRW2024-08-14
04012030021081seca 442seca GmbH & Co. KGFRW2024-05-07
04012030021470seca 495seca GmbH & Co. KGFRW2024-05-01
04012030021487seca 495 rseca GmbH & Co. KGFRW2024-05-01
04012030021494seca 496seca GmbH & Co. KGFRW2024-05-01
04012030021500seca 604seca GmbH & Co. KGFRW2024-05-01
04012030021593seca 404seca GmbH & Co. KGFRW2024-05-01
04012030021609seca 446seca GmbH & Co. KGFRW2024-05-01
04012030021616seca 448seca GmbH & Co. KGFRW2024-05-01
04012030021623seca 476seca GmbH & Co. KGFRW2024-05-01
04012030021630seca 405seca GmbH & Co. KGFRW2024-05-01
04012030021647seca 438seca GmbH & Co. KGFRW2024-05-01
00841447109938Invacare(R) Reliant(TM)INVACARE CORPORATIONFRW2024-04-19
04719846014893CharderCHARDER ELECTRONIC CO., LTD.FRW2024-04-17
00817517026917HopkinsMARKETLAB INC.FRW2023-09-08