Model 6653

Primary DI
04035479143541
Brand
Model 6653
Company
BIOTRONIK SE & Co. KG
Model
405231
Catalog number
405231
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
OTC
false
Sterile
true
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035479143541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035479143541040354791435414035479143541

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 Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04035479189235SW HMSC 3.654966314966312026-01-20
04035479162054Selectra 3D-40-324436244436242020-11-12
04035479162061Selectra 3D-40-394436254436252020-11-12
04035479162078Selectra 3D-55-324436264436262020-11-12
04035479162085Selectra 3D-55-394436274436272020-11-12
04035479162092Selectra 3D-65-324436284436282020-11-12
04035479162108Selectra 3D-65-394436294436292020-11-12
07640130455399Selectra3D-40-424517892020-11-12
07640130455405Selectra3D-55-424517902020-11-12
07640130455412Selectra3D-65-424517912020-11-12
04035479176228Selectra 3D-65-424517914517912021-06-02
04035479176235Selectra 3D-55-424517904517902021-06-02
04035479176242Selectra 3D-40-424517894517892021-06-02
04035479116828SelectraIC-50-653755452014-08-27
04035479116835SelectraIC-50-753755462014-08-27
04035479116842SelectraIC-90-653755472014-08-27
04035479116859SelectraIC-90-753755482014-08-27
04035479116651Selectra Amplatz 6.0-453755193755192014-08-27
04035479116668Selectra Amplatz 6.0-553755203755202014-08-27
04035479116675Selectra BIO2-453755233755232014-08-27

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
04035479143534Model 6646BIOTRONIK 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