AcuNav Volume ICE Catheter

GUDID 04056869275079

SIEMENS MEDICAL SOLUTIONS USA, INC.

Intracardiac ultrasound imaging catheter, steerable, single-use

Primary Device ID	04056869275079
NIH Device Record Key	9ac46340-01a3-47af-a198-e18c16fa404c
Commercial Distribution Status	In Commercial Distribution
Brand Name	AcuNav Volume ICE Catheter
Version Model Number	11508800
Company DUNS	804722783
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	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
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

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056869275079 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163478
Premarket Notification: K212959

FDA Product Code

OBJ	Catheter, ultrasound, intravascular

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[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 Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-03-14
Device Publish Date	2022-03-04

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