AcuNav Volume Ultrasound Catheter

GUDID 04056869004266

SIEMENS MEDICAL SOLUTIONS USA, INC.

Intracardiac ultrasound imaging catheter, steerable, single-use

Primary Device ID	04056869004266
NIH Device Record Key	7f0b1134-6cee-46ac-a84f-65de47aa9c00
Commercial Distribution Status	In Commercial Distribution
Brand Name	AcuNav Volume Ultrasound Catheter
Version Model Number	10855958
Company DUNS	136120750
Company Name	SIEMENS MEDICAL SOLUTIONS USA, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	XX@XX.XX
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM
Phone	+1(800)888-7436
Email	CONTACT@SIEMENS-HEALTHINEERS.COM

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French
Device Size Text, specify	0
Catheter Gauge	12.5 French

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869004266 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173618

FDA Product Code

OBJ	Catheter, ultrasound, intravascular

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[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 Status	Update
Device Record Status	Published
Public Version Number	2
Public Version Date	2019-03-21
Device Publish Date	2019-02-09

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