Advanced Infant Warmer
Catalogue number A4051, listed by Advanced Instrumentations, Inc., United States, under Incubator, Neonatal. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol (Changzhou) Connector Systems Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Advanced Instrumentations, Inc., United States |
|---|---|
| FDA product code | FMZ |
| Device type | Incubator, Neonatal |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5400 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-02-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4051 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tarry Probes | Tarry Medical Products, Inc. | 7 |
| Midas Rex MR8 | Medtronic Powered Surgical Solutions | 6 |
| Airlife | AirLife Finland Oy | 6 |
| AirLife | Carefusion Finland 320 Oy | 5 |
| Multi-Link™ | AirLife Finland Oy | 3 |
| Access Medical Probes | Tarry Medical Products, Inc. | 3 |
| Advanced Neonatal Incubator | Advanced Instrumentations, Inc. | 2 |
| Babyleo TN500 | Drägerwerk AG & Co. KGaA | 2 |
| Isolette® 8000 plus | Draeger Medical Systems, Inc. | 2 |
| Isolette 8000 Infant Incubator | Draeger Medical Systems, Inc. | 1 |
| Skin Temp Probe, 5mm O.D.(Y) | Atom Medical Corporation | 1 |
| Oxygen Sensor For Dual Incu i, Incu i, V-2200/2100G(2 pcs/set) | Atom Medical Corporation | 1 |
Showing 12 of 41. All products under Incubator, Neonatal
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.