EP-NurseMate™ NM-02

GUDID 05414734207782

Physio Module

ST. JUDE MEDICAL, INC.

Cardiac catheterization monitoring system
Primary Device ID05414734207782
NIH Device Record Keybfe90335-1849-4ed1-b0e2-24f3b59f331d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEP-NurseMate™
Version Model NumberStation
Catalog NumberNM-02
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

Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734207782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-10

On-Brand Devices [EP-NurseMate™]

05415067000972H700097
05414734207782Physio Module

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