PressureWire™ C17040

GUDID 05415067000118

Signal Receiver Kit

ST. JUDE MEDICAL, INC.

Catheter-tip transducer, pressure
Primary Device ID05415067000118
NIH Device Record Keyc1b6a1cf-0125-4866-b479-a0fe2d818efb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePressureWire™
Version Model NumberReceiver
Catalog NumberC17040
Company DUNS149818952
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067000118 [Primary]

FDA Product Code

DXOTRANSDUCER, PRESSURE, CATHETER TIP

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-11
Device Publish Date2016-04-21

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Trademark Results [PressureWire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRESSUREWIRE
PRESSUREWIRE
75786514 2590269 Live/Registered
ST. JUDE MEDICAL COORDINATION CENTER BVBA
1998-08-04

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