ACU 1060.2 Transtracheal Catheter
ACU 1060.2 Transtracheal Catheter provides tracheal access for manual jet ventilators. The attached syringe helps to determine correct needle placement in the trachea by air aspiration.…
ACU 1060.2 Transtracheal Catheter provides tracheal access for manual jet ventilators. The attached syringe helps to determine correct needle placement in the trachea by air aspiration. Needle size: 14Gauge / Child RX only.
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 | Instrumentation Industries, Incorporated, 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) | K955461 |
| Record published | 2021-01-13 |
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, manufacturing date |
| Sizes | Needle gauge 14 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACU 1060.2 | Needle Gauge 14 G | 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)
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 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-09-23 | Class II | Nonconforming Material/Component | As a distributor of tubing manufactured by Smooth Bore Plastics, we are initiating a product recall for specific lots of KC 036, KC 060 and KC 072 reusable ventilator tubes due to a possible manufacturing defect: A few tubes may have the p | 567 | 2016-11-28 |
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.