Assurityâ„¢ PM1240

GUDID 05414734507066

Pulse Generator SSIR     

ST. JUDE MEDICAL, INC.

Single-chamber implantable pacemaker, rate-responsive
Primary Device ID05414734507066
NIH Device Record Keyf8d15d6c-de0c-49d2-bd59-b96636a3faf6
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssurityâ„¢
Version Model NumberSR
Catalog NumberPM1240
Company DUNS790268031
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter
Total Volume10.4 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
Handling Environment TemperatureBetween -5 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Keep away from sunlight. Protect from heat and radioactive sources.
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734507066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVZPulse generator, permanent, implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-04-10

On-Brand Devices [Assurityâ„¢]

05414734507097Pulse Generator DDDR                                      Â
05414734507080Pulse Generator SSIR                                     
05414734507073Pulse Generator DDDR                                      Â
05414734507066Pulse Generator SSIR     

Trademark Results [Assurity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASSURITY
ASSURITY
97352250 not registered Live/Pending
Achieving Joy LLC
2022-04-07
ASSURITY
ASSURITY
88707462 not registered Live/Pending
AHF, LLC
2019-11-26
ASSURITY
ASSURITY
88682354 not registered Live/Pending
Assurity Secure, LLC
2019-11-06
ASSURITY
ASSURITY
85707065 4397624 Live/Registered
Pacesetter, Inc.
2012-08-17
ASSURITY
ASSURITY
78480711 3100082 Live/Registered
Assurity Life Insurance Company
2004-09-09
ASSURITY
ASSURITY
78480372 3070343 Live/Registered
Assurity Life Insurance Company
2004-09-08
ASSURITY
ASSURITY
78407417 2997466 Dead/Cancelled
Assurity Financial Services, LLC
2004-04-23
ASSURITY
ASSURITY
78303457 not registered Dead/Abandoned
Harris Corporation
2003-09-22
ASSURITY
ASSURITY
77375362 3944644 Dead/Cancelled
Eli Lilly and Company
2008-01-18
ASSURITY
ASSURITY
77375359 not registered Dead/Abandoned
Eli Lilly and Company
2008-01-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.