FDA Registration
Active
🇺🇸 United States
TRUER MEDICAL, INC.
Reg #: 2032273
·
FEI: 3003240904
·
Expires 2026
Products
8
Proprietary Names
15
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- TRUER MEDICAL, INC.
- Registration Number
- 2032273
- FEI Number
- 3003240904
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1050 N Batavia St Ste C
- City
- ORANGE
- State
- CA
- ZIP
- 92867
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101244
Owner / Operator
- Firm Name
- TRUER MEDICAL, INC.
- Operator Number
- 9043471
- Address
- 1050 NORTH BATAVIA, UNIT C, --
- City
- Orange
- State
- CA
- Postal Code
- 92867
- Country
- US
- Correspondent
- Tim - Truitt
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bougie, Esophageal, Ent | KCD | Class 1 | Ear, Nose, Throat | No | 2010-06-08 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2000-10-26 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2015-09-11 |
| Mouthguard, Prescription | MQC | Class U | Unknown | No | 2013-05-28 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2000-11-13 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2010-12-06 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2022-06-30 |
| Stethoscope, Esophageal, With Electrical Conductors | BZT | Class 2 | Anesthesiology | No | 2010-06-08 |
Proprietary Names
Voir Bougie
Tactical Bougie
Truer Bougie
Gas Sampling Line
Truer Medical, Inc. Head Strap
Migratherapy LLC
TMJ QuickSplint
Quick Spint
Intubation Stylet
RPiS
RAPID POSITIONING INTUBATION STYLET
General Purpose Probes, Tympanic Probes, Skin Sensing Probes
HP 400 Series Type Monitor Cable
400 Series Type Monitor Cable, Right Angle
Esophageal Stethoscope
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device