Product Code: OSR


Products Classified as OSR

1072Pacemaker/icd/crt Non-implanted Components

Total Product Life Cycle (TPLC) Devices

1072Pacemaker/icd/crt Non-implanted Components

FDA Consensus Standards

Pacemaker/Icd/Crt Non-Implanted Components [36797]21 CFR Unclassified 🔎

Pre-market Approvals for OSR

P890003MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORSMedtronic, Inc.
P910077MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)BOSTON SCIENTIFIC
P980049PARADYM RF VR 9250 PARADYM RF DR 9550MicroPort CRM USA Inc.
P010031BRAVA,BRAVA QUAD,CONCERTO II,CONSULTA,MAXIMO II,PROTECTA,PROTECTA XT,VIVA QUAD S, VIVA QUAD XT,VIVA S, VIVA XT CRT-DS, CMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
P950037ACTROS/AXIOS DR/SR/SLR/D/S, BA03 DDDR, CYLOS DR/DR-T/VR, DROMOS DR/SR/SL, KAIROS DR/SR/SL/D/S, PHILOS DR/DBIOTRONIK, INC.
P010012COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DSBoston Scientific Corp.

Global Unique Device Identification Database

00613994952400Pacemaker/icd/crt non-implanted components
00613994909565Pacemaker/icd/crt non-implanted components
00613994581594Pacemaker/icd/crt non-implanted components
00613994581570Pacemaker/icd/crt non-implanted components
00613994524232Pacemaker/icd/crt non-implanted components
00613994381071Pacemaker/icd/crt non-implanted components
00613994362896Pacemaker/icd/crt non-implanted components
00613994175397Pacemaker/icd/crt non-implanted components
00613994119995Pacemaker/icd/crt non-implanted components
00643169947115Pacemaker/icd/crt non-implanted components
00643169763548Pacemaker/icd/crt non-implanted components
00643169725379Pacemaker/icd/crt non-implanted components
00643169703247Pacemaker/icd/crt non-implanted components
00643169703223Pacemaker/icd/crt non-implanted components
00643169703193Pacemaker/icd/crt non-implanted components

Maude Adverse Events

SMART MONITORMANUFACTURED FOR MICROPORT CRM S.R.L.2020-01-31
LATITUDE COMMUNICATORJABIL CIRCUIT (SHANGHAI) LTD2020-01-15
LATITUDE COMMUNICATORPLEXUS2020-01-15
LATITUDE COMMUNICATORJABIL CIRCUIT (SHANGHAI) LTD2020-01-15
LATITUDE COMMUNICATORJABIL CIRCUIT (SHANGHAI) LTD2020-01-15
SMART MONITORMANUFACTURED FOR MICROPORT CRM S.R.L.2019-12-05
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-10-18
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-10-11
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-09-10
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-09-04
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-09-02
SMARTVIEW HOTSPOTSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-09-02
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-09-02
ADAPTERST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)2019-08-30
SMARTTOUCHMANUFACTURED FOR MICROPORT CRM S.R.L.2019-08-26
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-08-26
BOSTON SCIENTIFIC LATITUDE ICDBOSTON SCIENTIFIC2019-08-16
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-08-12
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-08-01
SMARTVIEW HOTSPOTSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-07-30
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-07-25
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-07-25
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-07-23
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-07-23
LATITUDE COMMUNICATORJABIL CIRCUIT (SHANGHAI) LTD2019-07-20
LATITUDE COMMUNICATORJABIL CIRCUIT (SHANGHAI) LTD2019-07-20
LATITUDE COMMUNICATORJABIL CIRCUIT (SHANGHAI) LTD2019-07-10
LATITUDE COMMUNICATORJABIL CIRCUIT (SHANGHAI) LTD2019-07-10
LATITUDE COMMUNICATORJABIL CIRCUIT (SHANGHAI) LTD2019-07-10
SMARTVIEW HOTSPOTSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-07-05
PHYSIQUE2019-07-02
SMARTVIEW HOTSPOTSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-06-14
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-05-27
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-05-24
SMARTVIEW HOTSPOTSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-04-18
REVEAL LINQ LOOP RECORDERMEDTRONIC2019-04-12
MYCARELINK PATIENT MONITORMEDTRONIC2019-04-12
MYCARELINK PATIENT MONITORMEDTRONIC2019-04-12
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-03-26
MERLIN@HOME TM TRANSMITTERST JUDE MEDICAL / ABBOTT LABORATORIES2019-03-26
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-03-26
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-03-26
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-03-22
ALTRUA PACEMAKERBOSTON SCIENTIFIC CORPORATION2019-03-18
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-01-22
SMARTVIEWSORIN GROUP ITALIA S.R.L. - CRM FACILITY2019-01-04
COMMUNICATOREXTERNAL MANUFACTURER2018-10-29
COMMUNICATOREXTERNAL MANUFACTURER2018-10-29
COMMUNICATOREXTERNAL MANUFACTURER2018-10-29
COMMUNICATOREXTERNAL MANUFACTURER2018-10-22

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