AcuNav Volume ICE Catheter

GUDID 04056869275079

SIEMENS MEDICAL SOLUTIONS USA, INC.

Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use
Primary Device ID04056869275079
NIH Device Record Key9ac46340-01a3-47af-a198-e18c16fa404c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcuNav Volume ICE Catheter
Version Model Number11508800
Company DUNS804722783
Company NameSIEMENS MEDICAL SOLUTIONS USA, 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 Datefalse
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(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(800)888-7436
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Device Dimensions

Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0
Catheter Gauge12.5 French
Device Size Text, specify0

Operating and Storage Conditions

Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104056869275079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBJCatheter, ultrasound, intravascular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

[04056869275079]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-14
Device Publish Date2022-03-04

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