Icare PATIENT

GUDID 06430033850985

Icare PATIENT

ICARE FINLAND OY

Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software
Primary Device ID06430033850985
NIH Device Record Key665a5aeb-543a-4def-add0-a6db057afede
Commercial Distribution StatusIn Commercial Distribution
Brand NameIcare PATIENT
Version Model NumberTS04
Company DUNS651755092
Company NameICARE FINLAND OY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS106430033850985 [Primary]
GS106430033850985 [Primary]
GS106430033850985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HKYTonometer, Manual
HKYTonometer, Manual
HKYTonometer, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

Devices Manufactured by ICARE FINLAND OY

06430033850985 - Icare PATIENT2020-05-19Icare PATIENT
06430033850985 - Icare PATIENT2020-05-19 Icare PATIENT
06430033851074 - Icare HOME tonometer2020-05-19
06430033850947 - Probes for HOME2020-05-12 Sales package 20pcs of TP022 probes
16430033850623 - Probes for HOME2020-05-12 Sales package 50pcs
06430033850626 - Probes for HOME2020-05-12 Single unit blister package
06430033850961 - Icare CLINIC2020-02-13 Icare CLINIC
06430033850978 - Icare EXPORT2020-02-13 Icare EXPORT
06430033851036 - Icare ic2002020-01-27 The Icare ic200 (TA031) tonometer is a hand-held, battery operated device, which measures intraocular pressure (IOP) without the

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