FDA.reportPublic FDA data

Home Monitoring Service Center

Primary DI
04035479152406
Brand
Home Monitoring Service Center
Company
BIOTRONIK SE & Co. KG
Model
3.34
Catalog number
419321
Published
2016-04-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479152406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479152406040354791524064035479152406

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information systemA dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. The system typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Contacts#

Phone, Email table
PhoneEmail
+1(888)345-0374jon.brumbaugh@biotronik.com

Regulatory Flags#

DUNS number
315620229
Device count
1
DM exempt
false
Premarket exempt
false
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
04035479110048Reocor S3655283655282014-08-13
04035479110055Reocor D3655293655292014-08-13
04035479114336Reocor D Redeladapter3712623712622014-08-21
04035479114343Reocor S Redeladapter3712633712632014-08-21
04035479114510Renamic PGH3715883715882014-08-21
04035479114527Renamic PGH ICD3715893715892014-08-21
04035479115142Renamic3719603719602014-08-12
04035479126391Renamic PSA Module3866103866102014-08-15
04035479143848Home Monitoring Service Center3.274053312014-08-21
04035479144241Home Monitoring Service Center3.284055522014-09-19
04035479144791BS IS-13308343308342014-08-04
04035479144807DH3316683316682014-08-14
04035479144968S 45-K1135881135882014-08-14
04035479144975S 45-S1300111300112014-08-14
04035479145019S 53-K1072351072352014-08-14
04035479145026S 53-S1300131300132014-08-14
04035479145033S 58-K1188771188772014-08-21
04035479148836Home Monitoring Service Center3.304084082015-04-22
04035479148850Home Monitoring Service Center3.324084102015-10-20
04035479157821EFH-6F-W4333064333062017-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479190538SW HMSC 3.66BIOTRONIK SE & Co. KGOSR2026-05-28
00802526628900LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-05-14
00802526627903LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2026-01-21
04035479189235SW HMSC 3.65BIOTRONIK SE & Co. KGOSR2026-01-20
04035479189044SW HMSC 3.64BIOTRONIK SE & Co. KGOSR2025-10-16
00802526625206LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2025-06-26
05415067049575Merlin™ST. JUDE MEDICAL, INC.OSR2025-06-25
04035479188689SW HMSC 3.63BIOTRONIK SE & Co. KGOSR2025-05-07
00763000812058NAMEDTRONIC, INC.OSR2025-04-12
04035479187927SW HMSC 3.62BIOTRONIK SE & Co. KGOSR2025-01-20
04035479188399NEO 2401.U/1BIOTRONIK SE & Co. KGOSR2024-12-18
05415067034809Merlin@home™ST. JUDE MEDICAL, INC.OSR2024-11-13
04035479176143Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-20
04035479187163Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-09-03
04035479186005NEOBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186012PSWBIOTRONIK SE & Co. KGOSR2024-06-17
04035479186128Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-05-29
00763000378356Instrument Command LibraryMEDTRONIC, INC.OSR2024-05-04
00763000378363Device Command LibraryMEDTRONIC, INC.OSR2024-05-04
04035479184636Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2024-01-10
04035479184285NEOBIOTRONIK SE & Co. KGOSR2023-12-15
04035479184292PSWBIOTRONIK SE & Co. KGOSR2023-12-15
04035479185510Renamic Neo NEOexpressBIOTRONIK SE & Co. KGOSR2023-12-15
00763000842536NAMEDTRONIC, INC.OSR2023-11-11
00802526622601LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2023-10-27
00802526622908LATITUDE™ Programming SystemBOSTON SCIENTIFIC CORPORATIONOSR2023-10-27
04035479183264Home Monitoring Service CenterBIOTRONIK SE & Co. KGOSR2023-10-13
04035479182960NEOBIOTRONIK SE & Co. KGOSR2023-08-23
04035479182977PSWBIOTRONIK SE & Co. KGOSR2023-08-23
04035479179632PSWBIOTRONIK SE & Co. KGOSR2023-08-15