Curaplex - OSCILLATORY PEP THERAPY SYSTEM,VIBRAPEP,OPEP,INTRODUCER,T-PIECE,LATEX FREE,DEHP FREE
2016-12-14
TRI-ANIM HEALTH SERVICES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010683054 | 3010683054 | TRI-ANIM HEALTH SERVICES, INC. | 1 | N | 2026-01-01 | Regulatory Affairs Department 5000 Bradenton Ave Dublin OH US 43017 |
| 3018759537 | 3018759537 | TRI-ANIM HEALTH SERVICES, INC. | 1 | Y | 2026-01-01 | 2911 S GREAT SW PARKWAY, STE 250 Grand Prairie TX US 75052 |
| 3006788778 | 3006788778 | Tri-anim Health Services, Inc. | 1 | Y | 2020-04-25 | 7320 Kingspointe Parkway Suite 530 Orlando FL US 32819 |
| 3008141784 | 3008141784 | Tri-anim Health Services, Inc. | 1 | Y | 2020-04-25 | 1605 ZEAGER RD Suite 102 Elizabethtown PA US 17022 |
| 3008382016 | 3008382016 | Tri-anim Health Services, Inc. | 1 | Y | 2020-04-25 | 481 Airport Industrial Drive Suite 103 Southaven MS US 38671 |
| 3008604179 | 3008604179 | Tri-anim Health Services, Inc. | 1 | Y | 2020-04-25 | 2241 North Plaza Drive Visalia CA US 93291 |
| 3010134184 | 3010134184 | Tri-anim Health Services, Inc. | 1 | Y | 2020-04-25 | 5235 International Drive Suite D Cudahy WI US 53110 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 319877 | 1405953651 | K220533 | Endoscopy Oxygen Mask | CCK | 2022-11-16 |
| 319877 | 1389927297 | K163091 | VibraPEP | BWF | 2017-02-21 |
| 319877 | 1444659463 | K153441 | VibraPEP | BWF | 2016-03-25 |
| 319877 | 1042995504 | ||||
| 319877 | 1370631461 | ||||
| 319877 | 1897454961 | ||||
| 319877 | 1906994986 | ||||
| 319877 | 1925606041 |
Product Codes Associated With Registrations#
GUDID#
Curaplex - Oscillatory PEP Therapy System, VibraPEP, No Tee
2017-04-18
Curaplex - Valved Tee Adapter, VibraPEP, 22mm OD x 18 mm ID, 22 mm ID side port
2017-04-18
Curaplex - Valved Tee Adapter, VibraPEP, 22mm OD x 18 mm ID, 22 mm ID side port
2019-07-01
Curaplex - VibraPEP 22mm Cap Adapter
2020-11-30
Curaplex - Curaplex Stoma Gel
2020-11-30
MiiS Horus Endoscope Display System -Video Box - A plug-and-play visualization device that works with a disposable endoscope to project images onto a monitor.
2025-08-12
Curaplex - HIGH FLOW CANNULA,25'*
2017-02-06
Curaplex - VibraPEP Valved Tee Adapter
2024-03-10
Curaplex - VibraPEP Oscillatory PEP Therapy Device Without Tee
2024-03-10
Curaplex - VibraPEP Oscillatory PEP Therapy Device
2024-03-10
Curaplex - VibraPEP Valved Tee Adapter
2024-03-10
Curaplex - VibraPEP Oscillatory PEP Therapy Device Without Tee
2024-03-10
Curaplex - VibraPEP Oscillatory PEP Therapy Device
2024-03-10
Curaplex - MASK,PrO2,OX,ADL,HI.CONC,ETCO2,M2M,30/BX
2024-01-10
Curaplex - MASK,PrO2,OX,ADL,HI.CONC,ETCO2,MS,30/BX
2024-01-10
Curaplex - MASK,PrO2,OX,ADL,MED.CONC,ETCO2,M2M,30/BX
2024-01-10
Curaplex - MASK,PrO2,OX,ADL,MED.CONC,ETCO2,MS,30/BX
2024-01-10
Curaplex - MASK,PrO2,OX,ADL,MED.CONC,ETCO2,30/BX
2024-01-10
Curaplex - MASK,PrO2,OX,ADL,HI.CONC,ETCO2,M2F,30/BX
2024-01-10
Curaplex - MASK,PrO2,OX,ADL,HI.CONC,ETCO2,30/BX
2024-01-10
Curaplex - MASK,PrO2,OX,ADL,MED.CONC,ETCO2,M2F,30/BX
2024-01-10
Curaplex - HANDLE,SUCTION,YANKAUER,STRAIGHT TIP,W/O CONTROL VENT,STERILE 50/CA
2017-02-06
Curaplex - HANDLE,SUCTION,YANKAUER,STRAIGHT TIP,W/O CONTROL VENT,STERILE 50/CA
2017-12-22
Curaplex - MASK,OX, ADL, 7', UNIVERSAL CONNECTOR
2019-02-10
Curaplex - MASK, OX, ADL, 7', NRB, 1VLV, UNIVERSAL CONNECTOR
2019-02-10
Curaplex - MASK, OX, ADL, 7', NRB, 2VLV, UNIVERSAL CONNECTOR
2019-02-10
Curaplex - MASK,OX, PED, 7', UNIVERSAL CONNECTOR
2019-02-10
Curaplex - MASK, VENTURI, ADL, UNIVERSAL CONNECTOR
2019-02-10
Curaplex - MASK, VENTURI, PED, UNIVERSAL CONNECTOR
2019-02-10
Curaplex - MASK,AEROSOL,ADL,UNDR CHN
2019-02-10
Curaplex - MASK,AEROSOL,PED,UNDR CHIN
2019-02-10
Curaplex - MASK,OX,ADL,7',50/CA
2019-02-10
Curaplex - MASK,OXY,ADL 50/CA
2019-02-10
Curaplex - MASK,OXY,ADL,SWIVEL 50/CA
2019-02-10
Curaplex - MASK,OX,AD,NOREBRTH,1VLV,7'
2019-02-10
Curaplex - MASK,OX,AD,NOREBRTH,2VLV,7'
2019-02-10
Curaplex - MASK,TRACH,PED,CURAPLEX,SPU
2019-02-10
Curaplex - MASK,TRACH,ADL,CURAPLEX,SPU
2019-02-10
Curaplex - MASK,OX,PED,7' 50/CS
2019-02-10