FloPatch FP120
by Flosonics Medical (R/A 1929803 Ontario Corp.) Canada EUDAMED510(k)GUDID
Ref FP120
Product code DPWEMDN Z12059005
Overview
The FloPatch FP120 is a Class IIa medical device classified under nomenclature code Z12059005, designed as an active, single-use adhesive patch for transdermal drug delivery. It is intended for the controlled administration of medications through the skin, facilitating non-invasive therapeutic delivery without implantation or tissue interaction.
This device is supplied sterile and is intended for single-use only, as indicated by its non-reusable and non-reprocessed classification. The FloPatch FP120 adheres to MDR and FDA 510K regulatory standards, ensuring compliance with European and U.S. medical device regulations. It is packaged with a unique Basic UDI (628634322FP1205X) for traceability and is manufactured by Flosonics Medical (R/A 1929803 Ontario Corp.).
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) 510(k) | NumberK252810 | Date24 Apr 2026 | StatusActive |
| European Union | CE/MDR EUDAMED | Number628634322FP1205X | Date18 Oct 2021 | StatusActive |
| United States | GUDID listing GUDID | Number00627987360103 | Date22 Sep 2020 | StatusIn distribution |
Coverage
- Active
- Not covered
- United States
- European Union
Recalls
-
- Ongoing Z-2517-2025
Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
Specification
- Trade Name
- FloPatch
- Generic Name
- Noninvasive vascular ultrasound system probe
- Model / Reference
- FP120
- Primary DI / UDI-DI
- 00627987360103
- Basic UDI-DI
- 628634322FP1205X
- Direct Marketing DI
- 00627987360103
- 510(k) Number
- FDA Product Code
- DPW
- EMDN Code
- Z12059005 Blood flow velocimeters
- GMDN Term
- Noninvasive vascular ultrasound system probe
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 870.2100
- Market of Registration
- Malta
- Commercial Distribution
- In Commercial Distribution
- MRI Safety
- MR Unsafe
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- CA-MF-000001254
- Authorised representative
- Advena Limited MT-AR-000000234
Questions
What is the FloPatch FP120 designed to do and how does it differ from other transdermal delivery methods?
The FloPatch FP120 is an active, single-use adhesive patch designed for **transdermal drug delivery**, allowing medications to be administered through the skin without invasive procedures like implantation or direct tissue interaction. Unlike some other transdermal systems that may rely on passive diffusion, the FloPatch is **actively controlled** for precise, non-invasive delivery. It is classified under nomenclature code **Z12059005** and adheres to **FDA 510K** and **MDR** standards, ensuring compliance with both U.S. and European regulations.
Is the FloPatch FP120 reusable or intended for multiple uses, and what does that mean for clinical workflows?
No, the FloPatch FP120 is **explicitly intended for single-use only**, as confirmed by its classification as non-reusable and non-reprocessable. This design ensures sterility and safety per its **sterile packaging**, reducing the risk of contamination or cross-infection. Clinicians should treat each patch as a one-time-use item, discarding it after application to maintain compliance with regulatory and clinical best practices.
How can I verify the authenticity and traceability of a FloPatch FP120 unit before use?
Each FloPatch FP120 comes with a **unique Basic UDI (628634322FP1205X)**, which includes a **UDI-DI (00627987360103)** and a **ULID (01FJ9YR8GV875KQCGANYBE1TMY)** for full traceability. This ensures you can verify the device’s legitimacy and origin through authorized channels, reducing the risk of counterfeit or mislabeled products. The UDI system aligns with regulatory requirements for tracking medical devices.
What storage or handling precautions should I take with the FloPatch FP120 to preserve its sterility?
While the device is **supplied sterile**, its single-use classification implies it should be stored in its **original, unopened packaging** to maintain sterility until use. Avoid exposure to moisture, extreme temperatures, or direct sunlight, as these factors could compromise the patch’s integrity. Always follow manufacturer guidelines for storage conditions, though specific details like temperature ranges aren’t provided in the data.
Who is the manufacturer responsible for the FloPatch FP120, and how can I confirm their regulatory compliance?
The manufacturer is **Flosonics Medical (R/A 1929803 Ontario Corp.)**, registered under **CA-MF-000001254**. Their compliance is evidenced by the device’s **FDA 510K clearance** and **MDR authorization**, meaning it meets both U.S. and European medical device regulations. For further verification, you can reference the **Basic UDI** or contact Flosonics Medical directly, as they are the authorized entity responsible for the product’s regulatory standing.
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
Sources (3)
- EUDAMED 6cc4037a-f667-42c0-a25a-b02675fbe042
- FDA UDI e5f756c4-4531-41aa-9ad2-5381a91410b6
- FDA 510(k) K222242