buprenorphine transdermal system
buprenorphine
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2182681 | 2182681 | LTS Therapy Systems, LLC | 1 | N | 2026-01-01 | 1685 MARTHALER LN. West St Paul MN US 55118 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10815611020005 | IontoPatch - The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis. | 651-552-5622 | steve.leno@ltslohmann.com |
| 10815611020012 | IontoPatch - The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis. | 651-552-5622 | steve.leno@ltslohmann.com |
| 10815611020029 | IontoPatch - The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis. | 612-245-7088 | mezzettj@tapemark.com |
| 10815611020036 | IontoPatch - The IontoPatch contains an innovative self-contained battery that produces an electric current to carry drug molecules non-invasively across the skin and to underlying tissue. There is no need for an external power source. Drug delivery is shut off automatically when the prescribed dosage has been administered. The IontoPatch is single use and disposable. Since there are no external batteries or wires, patients are able to return to their daily activities wearing the patch and receiving time-released iontophoresis. | 651-552-5622 | steve.leno@ltslohmann.com |
| 20815611021009 | Travanti - This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 10815611020005 2) Saline: Primary DI Number, 04026704396047 The IontoPatch is single use and disposable. The patch is used in conjunction with the saline. | 651-552-5622 | steve.leno@ltslohmann.com |
| 20815611021016 | Travanti - This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 10815611020012 2) Saline: Primary DI Number, 04026704396047 The IontoPatch is single use and disposable. The patch is used in conjunction with the saline. | 651-552-5622 | steve.leno@ltslohmann.com |
| 20815611021023 | Travanti - This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 10815611020029 2) Saline: Primary DI Number, 04026704396047 The IontoPatch is single use and disposable. The patch is used in conjunction with the saline. | 651-552-5622 | steve.leno@ltslohmann.com |
| 20815611021030 | Travanti - This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 10815611020036 2) Saline: Primary DI Number, 04026704396047 The IontoPatch is single use and disposable. The patch is used in conjunction with the saline. | 651-552-5622 | steve.leno@ltslohmann.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 35715 | 1434033476 | K992708 | IONTOPATCH | EGJ | 2000-02-01 |
| 35715 | 1063354226 | K102404 | PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) | OHP | 2010-12-02 |
| 35715 | 1291095688 | ||||
| 35715 | 1405485057 | ||||
| 35715 | 1774073913 |
buprenorphine
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