Blom
51 catalogue numbers from 313-11-080, listed by Pulmodyne Inc., United States, under Tube, Tracheostomy (W/Wo Connector). 1 manufacturer in China is registered for this product code.
1manufacturer
51catalogue numbers in this listing
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 | Pulmodyne 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, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K062104 |
| Record published | 2015-11-13 |
| Record revised | 2023-07-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10, pack of 100 |
| Sizes | Lumen/inner diameter 5 to 74 mm; outer diameter 9.4 to 13.8 mm; length 62 to 79 mm |
| Distribution end date | 2023-07-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 313-11-080 | Length 79 mm | In distribution |
| 313-14-040 | Outer Diameter 9.4 mm | In distribution |
| 313-00-080 | #8 | In distribution |
| 313-50-060 | #6 | In distribution |
| 313-40-040 | #4 | In distribution |
| 313-20-100 | #10 | In distribution |
| 313-50-100 | #10 | In distribution |
| 313-11-060 | Lumen/Inner Diameter 74 mm | In distribution |
| 313-12-040 | Length 62 mm | In distribution |
| 313-12-060 | Outer Diameter 10.8 mm | In distribution |
| 313-00-060 | #6 | In distribution |
| 313-40-080 | #8 | In distribution |
| 313-22-100 | #10 | In distribution |
| 313-20-080 | #8 | In distribution |
| 313-30-060 | #6 | In distribution |
| 313-10-080 | Length 79 mm | In distribution |
| 313-13-100 | Length 79 mm | In distribution |
| 313-11-040 | Length 62 mm | In distribution |
| 313-22-040 | #4 | In distribution |
| 313-40-060 | #6 | In distribution |
| 313-13-080 | Length 79 mm | In distribution |
| 313-14-080 | Length 79 mm | In distribution |
| 3113-00-100 | #10 | In distribution |
| 313-12-100 | Length 79 mm | In distribution |
| 313-01-080 | #8 | In distribution |
| 313-10-060 | Length 74 mm | In distribution |
| 313-50-040 | #4 | In distribution |
| 313-30-100 | #10 | In distribution |
| 313-01-060 | #6 | In distribution |
| 313-14-060 | Lumen/Inner Diameter 6.4 mm | In distribution |
| 313-20-040 | #4 | In distribution |
| 313-71-015 | In distribution | |
| 313-30-040 | #4 | In distribution |
| 313-50-080 | #8 | In distribution |
| 313-11-100 | Length 79 mm | In distribution |
| 313-70-000 | In distribution | |
| 313-13-040 | Length 62 mm | In distribution |
| 313-20-060 | #6 | In distribution |
| 313-00-040 | #4 | In distribution |
| 313-01-100 | #10 | In distribution |
| 313-40-100 | #10 | In distribution |
| 313-10-100 | Length 79 mm | In distribution |
| 313-13-060 | Length 74 mm | In distribution |
| 313-10-040 | Length 62 mm | In distribution |
| 313-22-060 | #6 | In distribution |
| 313-71-000 | In distribution | |
| 313-01-040 | #4 | In distribution |
| 313-30-080 | #8 | In distribution |
| 313-14-100 | Length 79 mm | In distribution |
| 313-12-080 | Length 79 mm | In distribution |
| 313-22-080 | #8 | Withdrawn |
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 |
| 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 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 30 |
Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)
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.