Level 1
16 catalogue numbers from ES700-9, listed by ICU Medical, Inc, United States, under Stethoscope, Esophageal, With Electrical Conductors. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
16catalogue numbers in this listing
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 | ICU 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K854212 |
| Record published | 2016-10-14 |
| Record revised | 2025-04-16 (version 6) |
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 |
| Packaging | Box of 20 |
| Distribution end date | 2019-08-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ES700-9 | In distribution | |
| ESTC-9 | In distribution | |
| ES70S-12 | In distribution | |
| ES70S-18 | In distribution | |
| ES700-24 | In distribution | |
| ES70S-24 | In distribution | |
| ES700-18 | In distribution | |
| ES400-12 | In distribution | |
| ESTC-24 | In distribution | |
| ES700-12 | In distribution | |
| ESTC-12 | In distribution | |
| ES400-18 | In distribution | |
| ES400-24 | In distribution | |
| ES400-9 | In distribution | |
| ESTC-18 | In distribution | |
| ES70S-09 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 40 |
| 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 |
| Starboard Temperature Probes | Starboard Medical, Inc. | 6 |
| 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 |
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.