Tube, Tracheostomy (W/Wo Connector)
Quicktrach II Emergency Cricothyrotomy Set for adult
1manufacturer
8catalogue numbers in this listing
1510(k) clearance
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 | VBM Medizintechnik Gmbh, Germany |
|---|---|
| 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) | K955461 |
| Record published | 2016-05-13 |
| Record revised | 2023-11-09 (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 |
| Storage | Special storage condition: Keep dry, Keep away from sunlight and heat |
| Packaging | Pack of 5 |
| Sizes | Needle gauge 13 to 16 G; lumen/inner diameter 4 mm |
| Distribution end date | 2023-11-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-02-918-1 | Needle Gauge 16 G | In distribution |
| 30-02-913-1 | Needle Gauge 13 G | In distribution |
| 30-02-013-1 | Needle Gauge 13 G | In distribution |
| 30-02-914-1 | Needle Gauge 14 G | In distribution |
| 30-02-014-1 | Needle Gauge 14 G | In distribution |
| 30-02-018-1 | Needle Gauge 16 G | In distribution |
| 30-10-004-1 | Lumen/Inner Diameter 4 mm | Withdrawn |
| 30-10-904-1 | Lumen/Inner Diameter 4 mm | Withdrawn |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 |
| 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 |
|---|---|
| K955461 | 1997-03-19 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Vbm Corp. | 510(k) number | 2011-05-09 | Not classified | Error in labeling | Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants. | 388 | 2012-03-14 |
| Vbm Corp. | 510(k) number | 2011-05-09 | Not classified | Error in labeling | Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants. | 29 | 2012-03-14 |
| Instrumentation Industries, Incorporated | 510(k) number | 2009-07-09 | Not classified | Component change control | user instructions not updated to correspond with product change | 396 units | 2009-10-15 |
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.