Elation™
23 catalogue numbers from 00884450198018, listed by Merit Medical Systems, Inc., United States, under Bronchoscope Accessory. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
23catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | KTI |
| Device type | Bronchoscope Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 874.4680 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-01-24 |
| Record revised | 2021-10-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450198018 | Balloon Length-3 cm | In distribution |
| 00884450398913 | Balloon Length-2 cm | In distribution |
| 00884450198001 | Balloon Length-3 cm | In distribution |
| 00884450398999 | Balloon Outer Diameters-6 mm, 7 mm, 8 mm | In distribution |
| 00884450398975 | Balloon Length-5.5 cm | In distribution |
| 00884450197974 | Balloon Length-2 cm | In distribution |
| 00884450398951 | Balloon Length-5.5 cm | In distribution |
| 00884450198032 | Catheter Length-100 cm | In distribution |
| 00884450198025 | Balloon Outer Diameters-12 mm, 13.5 mm, 15 mm | In distribution |
| 00884450398937 | Balloon Length-2 cm | In distribution |
| 00884450398944 | Balloon Length-3 cm | In distribution |
| 00884450399002 | Catheter Length-100 cm | In distribution |
| 00884450197950 | Balloon Length-2 cm | In distribution |
| 00884450593837 | Catheter Length-100 cm | In distribution |
| 00884450198056 | Balloon Length-5.5 cm | In distribution |
| 00884450197967 | Balloon Outer Diameters-8 mm, 9 mm, 10 mm | In distribution |
| 00884450398920 | Balloon Outer Diameters-10 mm, 11 mm, 12 mm | In distribution |
| 00884450197998 | Balloon Length-3 cm | In distribution |
| 00884450398982 | Balloon Length-2 cm | In distribution |
| 00884450399019 | Catheter Length-100 cm | In distribution |
| 00884450398968 | Balloon Length-5.5 cm | In distribution |
| 00884450197981 | Catheter Length-100 cm | In distribution |
| 00884450198049 | Balloon Outer Diameters-15 mm, 16.5 mm, 18 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bronchoscope Accessory | Richard Wolf Gmbh | 42 |
| MultiStage® | Dongguan TT Medical, Inc. | 24 |
| Inspira AIR | Acclarent, Inc. | 14 |
| Texas | Richard Wolf Gmbh | 10 |
| Trachealator Non-occlusive Airway Dilation Balloon | Disa Medinotec (PTY) Ltd | 9 |
| Pilling | Teleflex Medical LLC | 8 |
| CRE Pulmonary | Boston Scientific Corporation | 6 |
| Single Use Aspiration Needle | Olympus Medical Systems Corp. | 5 |
| Cook | Cook Incorporated | 3 |
| Areus(TM) Endobronchial Ultrasound Aspiration Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Trident(TM) Endobronchial Ultrasound Biopsy Needle | Micro-Tech (Nanjing) Co., Ltd. | 3 |
| Compass Steerable Needle | Serpex Medical, Inc. | 2 |
Showing 12 of 37. All products under Bronchoscope Accessory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213434 | 2022-03-08 |
| K161392 | 2016-09-01 |
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.