Level 1
Catalogue number ES100-9, listed by ICU Medical, Inc, United States, under Stethoscope, Esophageal. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BZW |
| Device type | Stethoscope, Esophageal |
| Device class | Class 1 |
| Regulation | 21 CFR 868.1910 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K823703 |
| Record published | 2016-10-14 |
| Record revised | 2025-04-16 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ES100-9 | In 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.