tapemark.combuprenorphine transdermal system
buprenorphine
LTS Therapy Systems, LLC
FDA Registration(s)#
| 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 |
GUDID Contact Samples#
| 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. | 612-245-7088 | mezzettj@tapemark.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. | 612-245-7088 | mezzettj@tapemark.com |
Registered Device Listings#
| 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 |
Product Codes Associated With Registrations#
NDC#
GUDID#
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.
2016-10-03
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.
2016-10-03
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.
2016-10-03
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.
2016-10-03
Travanti - This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 108156110200052) Saline: Primary DI Number, 04026704396047The IontoPatch is single use and disposable. The patch is used in conjunction with the saline.
2016-10-03
Travanti - This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 108156110200122) Saline: Primary DI Number, 04026704396047The IontoPatch is single use and disposable. The patch is used in conjunction with the saline.
2016-10-03
Travanti - This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 108156110200292) Saline: Primary DI Number, 04026704396047The IontoPatch is single use and disposable. The patch is used in conjunction with the saline.
2016-10-03
Travanti - This kit contains two (2) devices: 1) IontoPatch: Primary DI Number, 108156110200362) Saline: Primary DI Number, 04026704396047The IontoPatch is single use and disposable. The patch is used in conjunction with the saline.
2016-10-03