Model 6646 405230

GUDID 04035479143534

BIOTRONIK SE & Co. KG

Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable Electrical-only medical device connection cable, reusable

Primary Device ID	04035479143534
NIH Device Record Key	b724bcfb-6cd4-46f5-b6c4-3222c75f3b5a
Commercial Distribution Discontinuation	2021-08-30
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Model 6646
Version Model Number	405230
Catalog Number	405230
Company DUNS	315620229
Company Name	BIOTRONIK SE & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Special Storage Condition, Specify	Between 0 and 0 *Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure	Between 50 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479143534 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P950037

FDA Product Code

OVJ	Pulse generator, external pacemaker, dual-chamber