FDA.reportPublic FDA data

Health o meter professional

Primary DI
00892076002749
Brand
Health o meter professional
Company
Pelstar, LLC
Model
597KG
Device description
Digital Eye-Level Scale
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

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
00892076002749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00892076002749008920760027498920760027490892076002749

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
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 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

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