Access Medical Probes
D-208-700/FC100 Single Use Skin Temperature Probe
2manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
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 | Tarry Medical Products, Inc., United States |
|---|---|
| FDA product code | FMZ |
| Device type | Incubator, Neonatal |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5400 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K071977 |
| Record published | 2018-09-13 |
| Record revised | 2026-02-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Packaging | Pack of 25, pack of 50 |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D-208-700/FC100 | Withdrawn | |
| D-DP697-700-HH | Withdrawn | |
| D-DP208-700HH | Withdrawn |
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 |
| 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 |
| Caleo | Drägerwerk AG & Co. KGaA | 1 |
Showing 12 of 41. All products under Incubator, Neonatal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071977 | 2008-05-23 |
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.