Z-MED II™
PDZ623 Special Zmed II 8X5X100
1manufacturer
33catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | B. Braun Interventional Systems, Inc., United States |
|---|---|
| FDA product code | OZT |
| Device type | Balloon Aortic Valvuloplasty |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1255 |
| 510(k) | K003052 |
| Record published | 2016-08-09 |
| Record revised | 2023-09-07 (version 9) |
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: Store at room temp; Special storage condition: Keep away from sunlight |
| Distribution end date | 2021-08-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 611710 | In distribution | |
| 611770 | In distribution | |
| 611658 | In distribution | |
| 611771 | In distribution | |
| 611763 | In distribution | |
| 611742 | In distribution | |
| 611743 | In distribution | |
| 611760 | In distribution | |
| 611738 | In distribution | |
| 611756 | In distribution | |
| 611740 | In distribution | |
| 611726 | In distribution | |
| 611802 | In distribution | |
| 611768 | In distribution | |
| 611745 | In distribution | |
| 611805 | In distribution | |
| 611741 | In distribution | |
| 611804 | In distribution | |
| 611735 | In distribution | |
| 611727 | In distribution | |
| 611761 | In distribution | |
| 611788 | In distribution | |
| 611715 | In distribution | |
| 611754 | In distribution | |
| 611655 | In distribution | |
| 611660 | In distribution | |
| 611700 | In distribution | |
| 611723 | Withdrawn | |
| 611704 | Withdrawn | |
| 611729 | Withdrawn | |
| 611724 | Withdrawn | |
| 611713 | Withdrawn | |
| 611714 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Z-MED™ | B. Braun Interventional Systems, Inc. | 60 |
| True Dilatation | Bard Peripheral Vascular, Inc. | 18 |
| Inoue Balloon A | Toray Industries, Inc. | 12 |
| V8 | Intervalve, Inc. | 12 |
| KardiaPSI | Intervention Tech, Inc. ; dba Corvention | 11 |
| NuCLEUS-X™ | B. Braun Interventional Systems, Inc. | 9 |
| ValvuloPro® | Dongguan TT Medical, Inc. | 6 |
| Vida® | Bard Peripheral Vascular, Inc. | 5 |
| True Flow | Bard Peripheral Vascular, Inc. | 5 |
| OutFlo Aortic Valve Valvuloplasty Dilatation Balloon Catheter | Disa Medinotec (PTY) Ltd | 5 |
| Edwards Balloon Catheter | Edwards Lifesciences Technology Sarl | 1 |
| Ascendra Balloon Aortic Valvuloplasty Catheter | Edwards Lifesciences Technology Sarl | 1 |
Showing 12 of 15. All products under Balloon Aortic Valvuloplasty
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.