InHealth Technologies; Blom-Singer
7 catalogue numbers from BE 6036, listed by Freudenberg Medical, LLC, United States, under Dilator, Tracheal. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Freudenberg Medical, LLC, United States |
|---|---|
| FDA product code | KCG |
| Device type | Dilator, Tracheal |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-01-01 |
| Record revised | 2024-12-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| BE 6036 | In distribution | ||
| BE 6096 | 10 | In distribution | |
| BE 2036 | In distribution | ||
| BE 2051 | In distribution | ||
| BE 2050 | In distribution | ||
| BE 6050 | In distribution | ||
| BE 2052 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pilling | Teleflex Medical LLC | 22 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 4 |
| V. Mueller | Steris Corporation | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| Sklar | Sklar Corporation | 4 |
| Millennium | Avalign Technologies, Inc. | 3 |
| Boss Instruments | Boss Instruments, Ltd. | 3 |
| Symmetry Trousseau | Aspen Surgical Products, Inc. | 3 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 3 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 3 |
| Trousseau Tracheal Dilator Retractor | Sontec Instruments, Inc. | 3 |
| Gimmi | Gimmi Gmbh | 2 |
Showing 12 of 26. All products under Dilator, Tracheal
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.