FDA.reportPublic FDA data

Model 6646

Primary DI
04035479143534
Brand
Model 6646
Company
BIOTRONIK SE & Co. KG
Model
405230
Catalog number
405230
Published
2015-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OVJPulse generator, external pacemaker, dual-chamber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVJPulse Generator, External Pacemaker, Dual ChamberCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950037079

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950037079DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSBiotronik, Inc.1996-10-11DXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479143534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479143534040354791435344035479143534

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
315620229
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479170295Tunneler L4578564578562026-05-28
04035479190538SW HMSC 3.664980924980922026-05-28
04035479182755Rivacor Sky DR-T4819824819822026-04-20
04035479182779Rivacor Sky VR-T DX4819834819832026-04-20
04035479182793Rivacor Sky VR-T4819844819842026-04-20
04035479182809Acticor Sky HF-T QP4819854819852026-04-20
04035479182816Acticor Sky HF-T4819864819862026-04-20
04035479182823Acticor Sky DR-T4819874819872026-04-20
04035479182830Acticor Sky VR-T DX4819884819882026-04-20
04035479182847Acticor Sky VR-T4819894819892026-04-20
04035479182854Rivacor Sky HF-T QP4819904819902026-04-20
04035479182861Rivacor Sky HF-T4819914819912026-04-20
04035479182984Rivacor Aura HF-T QP4820124820122026-04-20
04035479182991Rivacor Aura HF-T4820134820132026-04-20
04035479183004Rivacor Aura DR-T4820144820142026-04-20
04035479183011Rivacor Aura VR-T4820154820152026-04-20
04035479183028Rivacor Rise HF-T QP7820164820162026-04-20
04035479183035Rivacor Rise HF-T4820174820172026-04-20
04035479183042Rivacor Rise DR-T4820184820182026-04-20
04035479183059Rivacor Rise VR-T DX4820194820192026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035479143176Model 3145BIOTRONIK SE & Co. KGOVJ2015-10-02
04035479143527Model 3150BIOTRONIK SE & Co. KGOVJ2015-10-01
04035479143541Model 6653BIOTRONIK SE & Co. KGOVJ2015-10-01
04035479114336Reocor D RedeladapterBIOTRONIK SE & Co. KGOVJ2014-08-21
04035479114343Reocor S RedeladapterBIOTRONIK SE & Co. KGOVJ2014-08-21
04035479143183Model 3145BIOTRONIK SE & Co. KGOVJ2014-08-21
04035479143190Model 3145BIOTRONIK SE & Co. KGOVJ2014-08-21
04035479110048Reocor SBIOTRONIK SE & Co. KGOVJ2014-08-13
04035479110055Reocor DBIOTRONIK SE & Co. KGOVJ2014-08-13
04035479110062ReliatyBIOTRONIK SE & Co. KGOVJ2014-08-08