FDA.report

Health o meter Professional

Primary DI
00850017694491
Brand
Health o meter Professional
Company
Pelstar, LLC
Model
2210KG4-AM
Device description
Antimicrobial High Resolution Digital Neonatal/Pediatric Four Sided Tray Scale; KG only
Published
2022-01-10
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
00850017694491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017694491008500176944918500176944910850017694491

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

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04012030021500seca 604seca GmbH & Co. KGFRW2024-05-01
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