AcuNav Volume Ultrasound Catheter

GUDID 04056869004266

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 Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use Intracardiac ultrasound imaging catheter, steerable, single-use
Primary Device ID04056869004266
NIH Device Record Key7f0b1134-6cee-46ac-a84f-65de47aa9c00
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcuNav Volume Ultrasound Catheter
Version Model Number10855958
Company DUNS136120750
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
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
Phone+1(800)888-7436
EmailXX@XX.XX
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

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104056869004266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBJCatheter, ultrasound, intravascular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

[04056869004266]

Ethylene Oxide

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-03-21
Device Publish Date2019-02-09

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