PILOT TLS

Primary DI
03660812159852
Brand
PILOT TLS
Company
MEDWIN FRANCE
Model
1
Catalog number
VSKTLSMUS
Device description
Pilot TLS is designed to support guidance and tip positioning of Peripherally Inserted Central Catheters(PICCs) of at least 3 Fr in size. Pilot TLS provides real-time catheter tip location information by using the patient’s cardiac electrical activity and is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation for adults. The device includes a medical tablet preloaded with Pilot software, a Pilot TLS module, an ECG cable accessory, and a Vygocard accessory.
Published
2025-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03660812159852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03660812159852036608121598523660812159852

GMDN Terms#

Term, Definition table
TermDefinition
Central venous catheter navigation system control unitA portable mains electricity (AC-powered) component of an electrocardiographic central venous catheter navigation system intended to process and display electrocardiographic (ECG) data to assist guidance and positioning of a central venous catheter [e.g., peripherally-inserted central catheter (PICC)]. It is a control unit with a monitor (e.g., a dedicated touchscreen unit) intended to be connected to the appropriate ECG cables/leads/catheter (not included). The technique involves the catheter functioning as an intravascular ECG electrode (using the guidewire or intraluminal saline as a conductor) which, along with skin surface ECG data, provides feedback on catheter tip location.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
390458888
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03660812138345PUGGLE4PG00012025-06-11
53660812136780PUGGLE4PG00012025-06-11

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