FDA Registration
Active
🇨🇳 China
SUNMED AP, LTD.
Reg #: 3005998497
·
FEI: 3005998497
·
Expires 2026
Products
18
Proprietary Names
41
Establishment Types
1
Classifications
18
Registration Details
- Registration Name
- SUNMED AP, LTD.
- Registration Number
- 3005998497
- FEI Number
- 3005998497
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6-9 ZHUFENG RD., QIANNAN INDUSTRIAL PARK, QIANWU TOWN, DOUMEN DISTRICT
- City
- ZHUHAI Guangdong
- Country
- CN
Owner / Operator
- Firm Name
- VENTLAB, LLC
- Operator Number
- 2246980
- Address
- 2710 Northridge Dr. NW, Suite A, --
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49544
- Country
- US
- Correspondent
- Rob Yamashita
US Agent
- Business Name
- AirLife
- Contact Name
- Rob Yamashita
- Address
- 2710 Northridge Drive NW - Suite A
- City
- Grand Rapids
- State
- MI
- ZIP
- 49544
- Country
- US
- [email protected]
- Phone
- 616 2598373
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2007-12-17 |
| Infusor, Pressure, For I.V. Bags | KZD | Class 1 | General Hospital | No | 2001-09-26 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 1992-11-19 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2006-08-03 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2006-08-03 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2007-12-17 |
| Resuscitator, Manual, Non Self-Inflating | NHK | Class 2 | Anesthesiology | No | 2007-12-17 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2013-07-27 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2024-09-06 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 1992-11-19 |
| Ventilator, Emergency, Powered (Resuscitator) | BTL | Class 2 | Anesthesiology | No | 2019-01-07 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2021-09-08 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2006-08-03 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2007-12-17 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2016-09-14 |
| Block, Bite | JXL | Class 2 | Neurology | No | 2023-02-17 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2001-07-24 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2026-05-19 |
Proprietary Names
BreathTech
Aerial
Alliance Tech Medical
Breathrite Spacer
Infu-Surg Bag
Pressure Infusion Bag
Infusor, Disposable, INFUSEIT
Oxygen Tubing
Ventlab Pressure Tubing and Accessories
Medline
Ventlab
Medline Disposable BV Filter
MedLine HME Filter
PEEP Valve
BreathTech Hyperinflation System
Ventlab Hyperinflation System
End Tidal CO2 Cannula
MedLine Cannula
DuraCheck Blood Pressure Cuffs
BreathTech Mask
Vent Mask
Soft-Aire Mask
Vent Mask II
Soft Seal Mask
SunMed SafeT T Piece Resuscitator
StatCheck II CO2 Indicator
Salter Labs Bubble Humidifier
Salter Labs Humidifer
Breathing Circuits
Colormetric etCO2 detector (MaxCap)
Provider Enterprise
CombiGuard
Bite Block
Block
GE Healthcare
Soft-Aire
Ventlab Oxygen Mask
NEOCHECK Blood Pressure Cuff
Zefron BP Cuffs
ComfortCheck Blood Pressure Cuff
Hyperinflation System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)