PatientCare 5002-0130

GUDID 06438147153275

Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.

Wallac Oy

Clinical laboratory information system
Primary Device ID06438147153275
NIH Device Record Keycf49630b-aeae-48d4-b65b-849d707e01f0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatientCare
Version Model Number5002-0130
Catalog Number5002-0130
Company DUNS540156544
Company NameWallac Oy
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106438147153275 [Primary]

FDA Product Code

JQPCalculator/Data Processing Module, For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-25

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06438147386963 - Iduronate 2-sulfatase S&IS2023-04-25 Vials contain Iduronate 2-sulfatase -substrate and Iduronate 2-sulfatase -internal standard, which can be used to measure the Id
06438147371815 - Qsight 210 MD Screening System2023-04-06
06438147384709 - Qsight 225 MD Screening System2023-04-06
06438147373901 - Eonis Analysis software2022-12-12 The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eo
06438147377718 - Eonis DNA Extraction kit2022-12-08 The Eonis DNA Extraction kit is a device intended for isolation and purification of DNA in newborn blood specimens dried on filt

Trademark Results [PatientCare]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PATIENTCARE
PATIENTCARE
88005023 not registered Dead/Abandoned
Paramedics Logistics Operating Company,LLC
2018-06-18

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