FDA Registration
Active
🇲🇽 Mexico
NextPhase Medical Devices Mexico LLC
Reg #: 3010882708
·
FEI: 3010882708
·
Expires 2026
Products
15
Proprietary Names
121
Establishment Types
1
Classifications
15
Registration Details
- Registration Name
- NextPhase Medical Devices Mexico LLC
- Registration Number
- 3010882708
- FEI Number
- 3010882708
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Tomas Alba Edison 19002, Parque Industrial Tomas Alba Edison, CP
- City
- TIJUANA Baja California
- Country
- MX
Owner / Operator
- Firm Name
- NextPhase Medical Devices LLC Mexico
- Operator Number
- 10046837
- Address
- Tomas Alba Edison 19002, Parque Industrial Tomas Alba Edison, CP
- City
- TIJUANA
- State
- Baja California
- Postal Code
- 22330
- Country
- MX
- Correspondent
- James G Bennett
US Agent
- Business Name
- NextPhase Medical Device, LLC
- Contact Name
- James G Bennett
- Address
- 88 Airport Dr
- City
- Rochester
- State
- NH
- ZIP
- 03867
- Country
- US
- [email protected]
- Phone
- 901 6878811
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2014-05-20 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2020-09-17 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2020-10-05 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2020-10-05 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2014-05-20 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2021-02-12 |
| Powered Microneedle Device | QAI | Class 2 | General, Plastic Surgery | No | 2023-12-12 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2024-02-27 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2020-08-06 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2026-02-24 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2026-02-24 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2026-02-24 |
| Saline, Vascular Access Flush | NGT | Class 2 | General Hospital | No | 2026-02-24 |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | Class 2 | General Hospital | No | 2021-06-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2021-02-12 |
Proprietary Names
Adapter Neonatal Disp Capnostat (1149448)
SPU Adult Airway ADPTR (1149466)
NEO PED DISP CO2 AA, Spacelabs (6947-00)
SPU INF Airway Adapter, Philips M2536A (1020709)
AIRWAY ADAPTER PED/INF NAFION (1149492)
AIRWAY ADAPTER ADU/PED (1149489)
SPU Neonatal AIRWY ADPTR (1149339)
SPU Ped-Adu Airway Adapter (6063-00)
Respironics Novametrix CapnoTrak Airway Adapter Set (1103414)
AIRWAY ADAPTER ADU/PED NAFION (1149491)
AIRWAY ADAPTER ADU/PED NAFION CAPNOFLEX (3173ADU-00)
AIRWAY ADAPTER PED/INF CAPNOFLEX (1149490)
SPU 15mm Male/Female Adptr (8935-25)
SPU NEO-PED Airway Adapter (6312-00)
Adult DISP CO2 AA, Spacelabs (6946-00)
AIRWAY ADAPTER ADU/PED CAPNOFLEX (3172ADU-00)
Adapter, 15mm SPU L Deadspace (8937-25)
SPU ADU Airway Adapter, Philips M2533A (1020711)
SPU PED Adult A ADPTR W MTHPC (6421-00)
Adapter Adult DISP Capnostat (1149386)
Respironics Novametrix CapnoTrak Airway Adapter Set (1103415)
CO2 NASAL CANNULA - INFANT, M2746A (3768INF-00)
CO2 NASAL CANNULA - PEDIATRIC, M2745A (3768PED-00)
AIRWAY, PEDIATRIC INFANT, ZOLL LOFLO, 10 (3572INF-00)
AIRWAY, ADULT PEDIATRIC, ZOLL LOFLO, 10 (3572ADU-00)
CANNULA, CO2, ADU, ZOLL LOFLO, 10 (3568ADU-00)
CANNULA, CO2 ORAL, PED, ZOLL LOFLO, 10 (3570PED-00)
AIRWAY, DEHUM TBG, PED INF, ZOLL LOFLO, 10 (3573INF-00)
CANNULA, CO2 ORAL, ADU, ZOLL LOFLO, 10 (3570ADU-00)
AIRWAY, DEHUM TBG, ADU PED, ZOLL LOFLO, 10 (3573ADU-00)
CANNULA, O2 CO2, PED, ZOLL LOFLO, 10 (3569PED-00)
CANNULA, CO2, INF, ZOLL LOFLO, 10 (3568INF-00)
CANNULA, O2 CO2, ADU, ZOLL LOFLO, 10 (3569ADU-00)
CANNULA, CO2, PED, ZOLL LOFLO, 10 (3568PED-00)
CANNULA, O2 CO2, INF, 10, ZOLL LOFLO (3569INF-00)
CANNULA, O2 CO2 ORAL, PED, ZOLL LOFLO, 10 (3571PED-00)
CANNULA, O2 CO2 ORAL, ADU, ZOLL LOFLO, 10 (3571ADU-00)
BITE-BLOK
SafetyNET Needle (21157-000)
SafetyNET Needle (21275-000)
SafetyNET Needle (18275-000)
CYTRELLIS DERMAL MICRO-CORING SYSTEM
CANNULA NASAL CO2 ADULT 704-0010-00 (3668ADU-00)
AIRWAY, ADU-PED, SLM LOFLO (3672ADU-00)
AIRWAY, DEHUM TBG, ADU PED, SLM LOFLO 10 (3673ADU-00)
CANNULA, NASAL, CO2/O2 ADU, 704-0014-00 (3669ADU-00)
AIRWAY ADAPTER KIT, PED/INF, 704-0024-00 (3672INF-00)
CANNULA NASAL/ORAL CO2/O2 ADU 704-0020-00 (3671PED-00)
AIRWAY ADAPTER PED/INF NAFION 704-0026-00 (3673INF-00)
SAMPLE LINE MALE LUER 704-0027-00 (3674-00)
CANNULA NASAL CO2/O2 PED 704-0016-00 (3669PED-00)
CANNULA NASAL CO2 PED 704-0012-00 (3668PED-00)
CANNULA NASAL CO2/O2 INF 704-0015-00 (3669INF-00)
CANNULA NASAL/ORAL CO2 ADU 704-0017-00 (3670ADU-00)
CANNULA, NASAL/ORAL, CO2/O2 ADU, 704-0020-00 (3671ADU-00)
SAMPLE LINE MALE LUER NAFION 704-0028-00 (3675-00)
LoFlo CO2 Sampling Cannula (1149484)
LoFlo CO2 Sampling Cannula INFANT/NEONATAL NASAL (3468INF-00)
LoFlo CO2 Sampling Cannula ADULT ORAL/NASAL (3470ADU-00)
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL (3469INH-00)
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL (3469ADH-00)
LoFlo CO2 Sampling Cannula (1149476)
LoFlo CO2 Sampling O2 Delivery Cannula ADULT ORAL/NASAL (3471ADU-00)
LoFlo CO2 Sampling Cannula (1149478)
LoFlo CO2 Sampling Cannula (1149435)
LoFlo Sampling Line Kit w/Dehumidification Tubing (1149495)
LoFlo Airway Adapter Kit ADULT/PEDIATRIC (3472ADU-00)
LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL (3470ADH-00)
LoFlo SAMPLING LINE KIT w/Dehumidification Tubing (3475-00)
LoFlo CO2 Sampling Cannula PEDIATRIC NASAL (3468PED-00)
LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL (3473INF-00)
LoFlo SAMPLING LINE KIT (3474-00)
LoFlo Airway Adapter Kit INFANT/NEONATAL (3472INF-00)
LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL (3468INH-00)
Sample Line-Female Luer Connector (3476-00)
LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC NASAL (3469PED-00)
LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL (3471PED-00)
LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric (3473ADU-00)
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL (3471ADH-00)
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL (3471PEH-00)
LoFlo Sampling Line Kit (1149494)
LoFlo CO2 Sampling O2 Delivery Cannula ADULT NASAL (3469ADU-00)
LoFlo CO2 Sampling Cannula (1149474)
LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL (3469PEH-00)
LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL (3468PEH-00)
LoFlo CO2 Sampling O2 Delivery Cannula INFANT/NEONATAL NASAL (3469INF-00)
LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL (3470PEH-00)
LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL (3468ADH-00)
LoFlo CO2 Sampling Cannula ADULT NASAL (3468ADU-00)
LoFlo CO2 Sampling Cannula PEDIATRIC ORAL/NASAL (3470PED-00)
CANNULA, NASAL/ORAL CO2/O2 PEDIATRIC (1149488)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 ORAL NASAL CANNULA (1105099)
CANNULA NASAL CO2/O2 PED CAPNOFLEX (3169PED-00)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 NASAL CANNULA (1103412)
INFANT NASAL CO2/O2 CANNULA (3169INF-00)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 NASAL CANNULA (1103411)
CANNULA, NASAL/ORAL, CO2, ADULT, CAPNOFLEX (1149484)
RESPIRONICS NOVAMETRIX CAPNOTRAK O2 DELIVERY EXTENSION LINE (1105137)
CANNULA, NASAL CO2/O2 INFANT (1149482)
RESPIRONICS NOVAMETRIX CAPNOTRAK WATER FILTER ASSEMBLY (1103416)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 ORAL NASAL CANNULA (1105098)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 ORAL NASAL CANNULA (1105100)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 NASAL CANNULA (1103413)
PEDI NASAL/ORAL CO2 ADU CANNULA CAPNOFLEX (3171PED-00)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 SAMPLING EXTENSION LINE (1105136)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 NASAL CANNULA (1103410)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2/O2 ORAL NASAL CANNULA (1105135)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 NASAL CANNULA (1103408)
CANNULA NASAL CO2/O2 ADULT CAPNOFLEX (3169ADU-00)
RESPIRONICS NOVAMETRIX CAPNOTRAK DEHUMIDIFICATION TUBING (1103417)
CANNULA, NASAL/ORAL CO2/O2 ADULT (1149379)
CANNULA, NASAL CO2/O2 PEDIATRIC (1149483)
CANNULA NASAL CO2/O2 ADULT (1149480)
CANNULA NASAL/ORAL CO2/O2 ADU CAPNOFLEX (3171ADU-00)
RESPIRONICS NOVAMETRIX CAPNOTRAK CO2 NASAL CANNULA (1103409)
PUMP, DISPOSABLE SUBASSEMBLY (PMI-SUB-15-380)
VALVE TUBING SET (PMI-SUB-15-381)
CVA130 - Halo 13mm Closed Vial Adaptor
CSA100 - Halo Closed Syringe Adaptor
CVA280 - Halo 28mm Closed Vial Adaptor
CVA200 - Halo 20mm Closed Vial Adaptor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)