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Pilot Tls

FDA UDI

Class II (US FDA UDI)

by Medwin France

Identity

Trade Name
PILOT TLS FDA UDI
Generic Name
Central venous catheter navigation system control unit FDA UDI
Device Name
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. FDA UDI
Model / Reference
1 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
VSKTLSMUS FDA UDI
Primary DI / UDI-DI
03660812159852 FDA UDI
FDA Product Code
LJS FDA UDI
GMDN Term
Central venous catheter navigation system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5970 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Central venous catheter navigation system control unit

Pilot Tls by Medwin France — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Central venous catheter navigation system control unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medwin France

Sources (1)

  • FDA UDI 1f259c87-09e0-43b4-86cb-429f9c6ef29c 34 fields · synced Jun 1, 2026