16750

GUDID 05415067045652

Lumbar Charging Apparel

ST. JUDE MEDICAL, INC.

Noninvasive device battery charger
Primary Device ID05415067045652
NIH Device Record Key5a93d579-83ef-4559-ac31-4dd1094538e9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number16750
Catalog Number16750
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)
Storage Environment TemperatureBetween 23 Degrees Celsius and 0
Storage Environment TemperatureBetween 73 Degrees Fahrenheit and 0
Special Storage Condition, SpecifyBetween 0 and 0 *Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73.4°F)

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067045652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LGWStimulator, spinal-cord, totally implanted for pain relief
NHLStimulator, electrical, implanted, for parkinsonian symptoms

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-12
Device Publish Date2023-01-04

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