TI500 Globetrotter Neonatal Transport System
Catalogue number MU20508, listed by Draeger Medical Systems, Inc., United States, under Incubator, Neonatal Transport. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
1recall
Who Else Makes It
Registered 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 |
Record
| Listed by | Draeger Medical Systems, Inc., United States |
|---|---|
| FDA product code | FPL |
| Device type | Incubator, Neonatal Transport |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5410 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K001019 |
| Record published | 2015-10-24 |
| Record revised | 2024-09-19 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MU20508 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 185A+ Infant Incubator | International Biomedical, Ltd. | 2 |
| Voyager Infant Transport Incubator | International Biomedical, Ltd. | 2 |
| NxtGen Infant Transport Incubator | International Biomedical, Ltd. | 2 |
| Reusable Skin Temperature Probes | Flexicare Medical Ltd. | 2 |
| LMT nomag® IC 1.5 | LMT Medical Systems Gmbh | 2 |
| Aviator Transport Incubator | International Biomedical, Ltd. | 2 |
| LMT nomag® IC 3.0 | LMT Medical Systems Gmbh | 2 |
| Disposable Skin Temperature Probes | Flexicare Medical Ltd. | 2 |
| Filter Element E(10 pcs/pkg) For V-808/V-850TR/V-80TR | Atom Medical Corporation | 1 |
| Advanced Transport Incubator | Advanced Instrumentations, Inc. | 1 |
| V-808 Main Unit Only(120 V) | Atom Medical Corporation | 1 |
| Oxygen Sensor For V-808 | Atom Medical Corporation | 1 |
Showing 12 of 18. All products under Incubator, Neonatal Transport
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141565 | 2014-09-10 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-05-20 | Class II | Under Investigation by firm | The firm has initiated this recall to replace component on devices distributed containing a component within the oxygen supply system that is not rated to the working pressure of the system. | 38 OUS (no US distribution) |
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.