AEROmini®
25 catalogue numbers from 00884450688861, listed by Merit Medical Systems, Inc., United States, under Prosthesis, Tracheal, Expandable. 1 manufacturer in China is registered for this product code.
1manufacturer
25catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | JCT |
| Device type | Prosthesis, Tracheal, Expandable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2022-12-31 |
| Record revised | 2021-11-08 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450688861 | Nominal Stent Diameter (mm)-12 mm | In distribution |
| 00884450688885 | Expanded Stent Length (mm)-10 mm | In distribution |
| 00884450230961 | Nominal Stent Diameter (mm)-8 mm | In distribution |
| 00884450230985 | Nominal Stent Diameter (mm)-10 mm | In distribution |
| 00884450229828 | Nominal Stent Diameter (mm)-8 mm | In distribution |
| 00884450688892 | Nominal Stent Diameter (mm)-8 mm | In distribution |
| 00884450688823 | Nominal Stent Diameter (mm)-10 mm | In distribution |
| 00884450688786 | Expanded Stent Length (mm)-15 mm | In distribution |
| 00884450307939 | Expanded Stent Length (mm)-10 mm | In distribution |
| 00884450307878 | Expanded Stent Length (mm)-10 mm | In distribution |
| 00884450230992 | Nominal Stent Diameter (mm)-8 mm | In distribution |
| 00884450229835 | Expanded Stent Length (mm)-15 mm | In distribution |
| 00884450688809 | Expanded Stent Length (mm)-15 mm | In distribution |
| 00884450362761 | Expanded Stent Length (mm)-15 mm | In distribution |
| 00884450688656 | Nominal Stent Diameter (mm)-8 mm | In distribution |
| 00884450688878 | Nominal Stent Diameter (mm)-14 mm | In distribution |
| 00884450307953 | Nominal Stent Diameter (mm)-14 mm | In distribution |
| 00884450307915 | Nominal Stent Diameter (mm)-8 mm | In distribution |
| 00884450688595 | Expanded Stent Length (mm)-15 mm | In distribution |
| 00884450710302 | Expanded Stent Length (mm)-15 mm | In distribution |
| 00884450307922 | Nominal Stent Diameter (mm)-10 mm | In distribution |
| 00884450229859 | Nominal Stent Diameter (mm)-14 mm | In distribution |
| 00884450229910 | Nominal Stent Diameter (mm)-8 mm | In distribution |
| 00884450688687 | Nominal Stent Diameter (mm)-10 mm | In distribution |
| 00884450229842 | Nominal Stent Diameter (mm)-12 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hanarostent® Trachea/Bronchium(CCC) | M.I.Tech Co Ltd | 84 |
| Bonastent® Tracheal/Bronchial | Sewoon Medical Co., Ltd. | 83 |
| Aero® | Merit Medical Systems, Inc. | 37 |
| Ultraflex™ Tracheobronchial | Boston Scientific Corporation | 36 |
| iCAST | Atrium Medical Corporation | 34 |
| Wallstent™ RP Endoprosthesis | Boston Scientific Corporation | 32 |
| Tracheal Stent system (Y-shaped) | Micro-Tech (Nanjing) Co., Ltd. | 27 |
| Aero DV® | Merit Medical Systems, Inc. | 27 |
| Wallgraft® | Boston Scientific Corporation | 25 |
| Through the Scope Tracheal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 17 |
| Wallstent® Endoprosthesis | Boston Scientific Corporation | 16 |
| Gianturco-Rosch Cook-Z | Cook Incorporated | 5 |
Showing 12 of 14. All products under Prosthesis, Tracheal, Expandable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181200 | 2018-09-21 |
| K140382 | 2014-11-25 |
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.