Montgomery® Long-Term Cannula
Size: 10 x 41
1manufacturer
48catalogue 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 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | 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 |
| Packaging | Carton |
| Sizes | Outer diameter 9 to 13 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 330849 | Fits Stoma Lengths of 41-49 mm | In distribution |
| 330441 | Size: 4 x 41 | In distribution |
| 331041 | Fits Stoma Lengths of 33-41 mm | In distribution |
| 331025 | Fits Stoma Lengths of 17-25 mm | In distribution |
| 331057 | Fits Stoma Lengths of 49-57 mm | In distribution |
| 330857 | Size: 8 x 57 | In distribution |
| 331033 | Size: 10 x 33 | In distribution |
| 331049 | Size: 10 x 49 | In distribution |
| 330665 | Outer Diameter 11 mm | In distribution |
| 330449 | Fits Stoma Lengths of 41-49 mm | In distribution |
| 330657 | Size: 6 x 57 | In distribution |
| 330865 | Fits Stoma Lengths of 57-65 mm | In distribution |
| 331065 | Size: 10 x 65 | In distribution |
| 331025 | Fits Stoma Lengths of 17-25 mm | In distribution |
| 330633 | Size: 6 x 33 | In distribution |
| 330849 | Fits Stoma Lengths of 41-49 mm | In distribution |
| 330857 | Size: 8 x 57 | In distribution |
| 330833 | Fits Stoma Lengths of 25-33 mm | In distribution |
| 330825 | Size: 8 x 25 | In distribution |
| 331065 | Size: 10 x 65 | In distribution |
| 330425 | Size: 4 x 25 | In distribution |
| 330457 | Size: 4 x 57 | In distribution |
| 330649 | Outer Diameter 11 mm | In distribution |
| 330833 | Fits Stoma Lengths of 25-33 mm | In distribution |
| 330657 | Size: 6 x 57 | In distribution |
| 330465 | Fits Stoma Lengths of 57-65 mm | In distribution |
| 330457 | Size: 4 x 57 | In distribution |
| 330649 | Outer Diameter 11 mm | In distribution |
| 330641 | Size: 6 x 41 | In distribution |
| 330825 | Size: 8 x 25 | In distribution |
| 330441 | Size: 4 x 41 | In distribution |
| 330625 | Fits Stoma Lengths of 17-25 mm | In distribution |
| 330665 | Outer Diameter 11 mm | In distribution |
| 330865 | Fits Stoma Lengths of 57-65 mm | In distribution |
| 330641 | Size: 6 x 41 | In distribution |
| 330425 | Size: 4 x 25 | In distribution |
| 331057 | Fits Stoma Lengths of 49-57 mm | In distribution |
| 331033 | Size: 10 x 33 | In distribution |
| 330841 | Size: 8 x 41 | In distribution |
| 330625 | Fits Stoma Lengths of 17-25 mm | In distribution |
| 331041 | Fits Stoma Lengths of 33-41 mm | In distribution |
| 330449 | Fits Stoma Lengths of 41-49 mm | In distribution |
| 330841 | Size: 8 x 41 | In distribution |
| 330433 | Fits Stoma Lengths of 25-33 mm | In distribution |
| 331049 | Size: 10 x 49 | In distribution |
| 330433 | Fits Stoma Lengths of 25-33 mm | In distribution |
| 330633 | Size: 6 x 33 | In distribution |
| 330465 | Fits Stoma Lengths of 57-65 mm | 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 |
| Bivona | ICU Medical, Inc | 37 |
| Well Lead Tracheostomy Tube | Well Lead Medical Co., Ltd. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 36 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 30 |
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.