FDA UDI
In Commercial Distribution
🇺🇸 United States
PILOT TLS
DI: 03660812159852
·
Model: 1
·
MEDWIN FRANCE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PILOT TLS
- Primary DI
- 03660812159852
- Version / Model
- 1
- Catalog Number
- VSKTLSMUS
- Company Name
- MEDWIN FRANCE
- Labeler DUNS
- 390458888
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-27
- Public Version
- 2
- Public Version Date
- 2025-07-07
- Public Version Status
- Update
- Public Device Record Key
- 1f259c87-09e0-43b4-86cb-429f9c6ef29c
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | General Hospital | 880.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61730 | Central venous catheter navigation system control unit | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03660812159852 | GS1 |