Starboard Temperature Probes
Starboard Temperature Probes provide continuous patient temperature monitoring when internal measurement is clinically indicated. Esophageal/rectal probes are designed for placement in the…
Starboard Temperature Probes provide continuous patient temperature monitoring when internal measurement is clinically indicated. Esophageal/rectal probes are designed for placement in the esophagus, nasopharynx or rectum. Esophageal stethoscope models combine temperature sensing with auscultation of heart and lung sounds.
The probes connect to monitoring instruments designed for YSI 400 series temperature probes or an equivalent interface. The range includes 9 and 12 French esophageal/rectal models and 9, 12, 18 and 24 French esophageal stethoscope models.
Listed Item
Esophageal/Rectal General Purpose 400 Series Temperature Sensor,12 Fr.
Placement and Supply
The stethoscope models are intended for esophageal placement. All probes are supplied sterile for single use. Selection of the measurement site depends on the clinical recommendation and the specific probe type.
Who Else Makes It
Concentrated in Shanghai (1), Fujian (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Inventech Xiamen Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 2 |
| Starboard Medical (Jiangsu) Co., Ltd. | Sheyang | Jiangsu | Contract manufacturer | 2 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Record
| Listed by | Starboard Medical, Inc., United States |
|---|---|
| FDA product code | BZT |
| Device type | Stethoscope, Esophageal, With Electrical Conductors |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1920 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K111050 |
| Record published | 2016-09-30 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Inner pack of 30, inner pack of 35 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 40012-ES | In distribution | |
| 40012-ER | In distribution | |
| 4009-ES | In distribution | |
| 40024-ES | In distribution | |
| 4009-ER | In distribution | |
| 40018-ES | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 40 |
| Level 1 | ICU Medical, Inc | 16 |
| sourcemark | Sourcemark, LLC. | 15 |
| Truer Medical, Inc. | Truer Medical, Inc. | 11 |
| Novatemp | Novamed-USA | 10 |
| Lifesound | Novamed-USA | 9 |
| Mon-a-Therm | Covidien LP | 8 |
| Medline | Medline Industries, Inc. | 6 |
| Temperature Probes | Philips Medical Systems Hsg | 3 |
| Tapscope | Cardiocommand, Inc. | 2 |
| Curaplex | Bound Tree Medical, LLC | 1 |
| EC-View | Cardiocommand, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140134 | 2014-06-16 |
| K111050 | 2012-04-12 |
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.