FDA Registration
Active
🇺🇸 United States
INTERNATIONAL BIOMEDICAL, LTD.
Reg #: 1625392
·
FEI: 1000058335
·
Expires 2026
Products
18
Proprietary Names
34
Establishment Types
2
Classifications
18
Registration Details
- Registration Name
- INTERNATIONAL BIOMEDICAL, LTD.
- Registration Number
- 1625392
- FEI Number
- 1000058335
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8206 Cross Park Dr
- City
- AUSTIN
- State
- TX
- ZIP
- 78754
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140707
Owner / Operator
- Firm Name
- INTERNATIONAL BIOMEDICAL, LTD.
- Operator Number
- 1629497
- Address
- 8206 CROSS PARK DR., P.O. BOX 143449
- City
- Austin
- State
- TX
- Postal Code
- 78754
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ventilator, Emergency, Powered (Resuscitator) | BTL | Class 2 | Anesthesiology | No | 2014-12-30 |
| Incubator, Neonatal Transport | FPL | Class 2 | General Hospital | No | 2022-07-19 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2022-11-21 |
| Pump, Infusion, Analytical Sampling | LZF | Class 2 | General Hospital | No | 2008-01-11 |
| Transilluminator, Battery-Powered | HJN | Class 1 | Ophthalmic | No | 2021-07-09 |
| Pad, Neonatal Eye | FOK | Class 1 | General Hospital | No | 2021-07-09 |
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2016-09-22 |
| Strip, Temperature, Forehead, Liquid Crystal | KPD | Class 2 | General Hospital | No | 2021-07-09 |
| Apparatus, Nitric Oxide Delivery | MRN | Class 2 | Anesthesiology | No | 2013-06-28 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2020-06-05 |
| Apparatus, Nitric Oxide, Backup Delivery | MRO | Class 2 | Anesthesiology | No | 2008-01-02 |
| Analyzer, Nitrogen Dioxide | MRQ | Class 2 | Anesthesiology | No | 2008-01-02 |
| Analyzer, Nitric Oxide | MRP | Class 2 | Anesthesiology | No | 2008-01-02 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2021-07-09 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2023-02-21 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2018-11-19 |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | Class 1 | Physical Medicine | No | 2022-11-21 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2025-03-31 |
Proprietary Names
Puffin Infant Resuscitator
LifeBorne Infant Resuscitator
NxtGen Infant Transport Incubator
InfaTherm Infant Warming Mattress
Glucose Monitor
Wee Sight Transilluminator
WeeSpecs Supreme
WeeSpecs
Airborne Phototherapy Light Bar
Voyager with Optional PulseOx Transport Incubator
Aviator with Optional PulseOx Transport Incubator
Voyager Transport Incubator
LC Accu-Bar Temp Trend Indicator
Aeronox Nitric Oxide Delivery System
Blood Gas Monitor
ECG Patient Cable
Puffin Lite Infant Resuscitator
AIRBORNE 750I INFANT
Aviator Transport Incubator
Aeronox
Squishon Mattress
Squishon 2, Gel Pillow
Gel-E Donut, Extra Small
Squishon 3, Gel Pillow
Gel-E Donut, Small
Gel_E Donut, Medium
NeoPod T Transport Humidifier
A750i with Optional PulseOx Transport Incubator
185A+ with Optional PulseOx Transport Incubator
NuBorne Infant Warmer
Infant Heel Warmer
Infant Heel Snuggler
TXP-2D Transport Ventilator
AeroNOx 2 Nitric Oxide Delivery Device
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198