Endurity™ PM1160

GUDID 05414734507042

Pulse Generator SSIR      

ST. JUDE MEDICAL, INC.

Single-chamber implantable pacemaker, rate-responsive
Primary Device ID05414734507042
NIH Device Record Keyb2ab3530-e862-42ba-a430-2ad81aea563d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndurity™
Version Model NumberSR
Catalog NumberPM1160
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
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter
Total Volume9.7 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734507042 [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 [Endurity™]

05414734507059Pulse Generator DDDR    
05414734507042Pulse Generator SSIR      

Trademark Results [Endurity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDURITY
ENDURITY
85707067 4397625 Live/Registered
Pacesetter, Inc.
2012-08-17

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