Cannula Faceplate
8 catalogue numbers from 310803, listed by Boston Medical Products, Inc., United States, under Tube, Tracheostomy (W/Wo Connector). 1 manufacturer in China is registered for this product code.
1manufacturer
8catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Boston Medical Products, Inc., United States |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K802916 |
| Record published | 2015-09-20 |
| Record revised | 2022-08-30 (version 5) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 310803 | Size: 8 | In distribution |
| 310403 | Size: 4 | In distribution |
| 310603 | Size: 6 | In distribution |
| 310803 | Size: 8 | In distribution |
| 311003 | Size: 10 | In distribution |
| 310403 | Size: 4 | In distribution |
| 310603 | Size: 6 | In distribution |
| 311003 | Size: 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tracoe® comfort | Tracoe Medical Gmbh | 1,296 |
| Portex | ICU Medical, Inc | 380 |
| Pilling | Teleflex Medical LLC | 248 |
| Premier | Premier Dental Products Co. | 111 |
| Tracoe mini | Tracoe Medical Gmbh | 110 |
| Sklar® | Sklar Corporation | 70 |
| Laryngotec | Andreas Fahl Medizintechnik-Vertrieb GmbH | 66 |
| Blom | Pulmodyne Inc. | 51 |
| Montgomery® Long-Term Cannula | Boston Medical Products, Inc. | 48 |
| Bivona | ICU Medical, Inc | 37 |
| Well Lead Tracheostomy Tube | Well Lead Medical Co., Ltd. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 36 |
Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K962240 | 1996-08-15 |
| K810978 | 1981-05-05 |
| K802916 | 1980-12-19 |
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.