FDA Registration
Active
🇺🇸 United States
EXIN MEDICAL TECHNOLOGY COMPANY, LLC
Reg #: 3015191173
·
FEI: 3015191173
·
Expires 2026
Products
19
Proprietary Names
17
Establishment Types
1
Classifications
19
Registration Details
- Registration Name
- EXIN MEDICAL TECHNOLOGY COMPANY, LLC
- Registration Number
- 3015191173
- FEI Number
- 3015191173
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2106 Scarlet Thistle Court
- City
- Katy
- State
- TX
- ZIP
- 77494
- Country
- US
Regulatory Submissions
- 510(k) Number
- K032878
Owner / Operator
- Firm Name
- Exin Medical Technology Company, LLC
- Operator Number
- 10059125
- Address
- 2106 scarlet thistle cr
- City
- Katy
- State
- TX
- Postal Code
- 77494
- Country
- US
- Correspondent
- Frank Chiang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2022-07-21 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2022-07-21 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2022-07-21 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2022-07-21 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2022-07-21 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-07-21 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2022-07-21 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2022-07-21 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2022-07-21 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2022-07-21 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2022-07-21 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2022-07-21 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2022-07-21 |
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2022-07-21 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2022-07-21 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2022-07-21 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2022-07-21 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2022-07-21 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2022-07-21 |
Proprietary Names
Nasal cannula
Reservoir bag/ Rebreathing bag
Mouth opener
HMEF
CPR face shield
Aerosol mask
Pressure Infusor Bag
Anesthesia mask/ Cushion mask/ Silicone mask
Humidifier
Oxygen tubing
Airway
Ventilator tubing
Anesthesia breathing circuit
Pocket size resuscitator
Nose clip
PVC Resuscitator and Accessories
Oxygen Adapter, Christmas Tree Adapter
Establishment Types
Repack or Relabel Medical Device