AcuNav Lumos 4D ICE catheter

GUDID 04056869997445

SIEMENS MEDICAL SOLUTIONS USA, INC.

Intracardiac ultrasound imaging catheter, steerable, single-use
Primary Device ID04056869997445
NIH Device Record Keyc5f2172c-f3ea-46e2-a9b8-e696cf9a9e1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcuNav Lumos 4D ICE catheter
Version Model Number11658641
Company DUNS804722783
Company NameSIEMENS MEDICAL SOLUTIONS USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Device Dimensions

Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French
Catheter Gauge12.5 French

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 23 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104056869997445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBJCatheter, ultrasound, intravascular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

[04056869997445]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-29
Device Publish Date2024-07-19

Devices Manufactured by SIEMENS MEDICAL SOLUTIONS USA, INC.

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04056869997445 - AcuNav Lumos 4D ICE catheter2024-07-29
04056869997445 - AcuNav Lumos 4D ICE catheter2024-07-29
04068151001303 - ACUSON P500 ICE Ultrasound System2024-07-09
04056869950747 - 6C1 HD Transducer2024-05-16
04056869950754 - 18L6HD Transducer2024-05-16
04056869954240 - 18L6 Transducer2024-05-16
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