Z-MED™
- Primary DI
- 04046964335853
- Brand
- Z-MED™
- Company
- B BRAUN INTERVENTIONAL SYSTEMS, INC
- Model
- 611669
- Catalog number
- 611669
- Device description
- SO073 Z-MED 33X4X100
- Published
- 2016-08-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Related Records
Contact Domains
bbraun.comProduct Codes
| Code | Name |
|---|---|
| LIT | Catheter, angioplasty, peripheral, transluminal |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04046964335853 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04046964335853 | 04046964335853 | 4046964335853 |
GMDN Terms
| Term | Definition |
|---|---|
| Cardiac valvuloplasty catheter | A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | |
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight |
| Special Storage Condition, Specify | 0 | 0 | ROOM TEMP AWAY FROM SUNLIGHT |
| Special Storage Condition, Specify | 0 | 0 | Store at room temp |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1(877)836-2228 | GUDID.BBMUS_Service@bbraun.com |
Regulatory Flags
- DUNS number
- 784259751
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Other Devices From This Company
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|---|---|---|---|---|
| 04046961018650 | ACCEL® | 622390 | 622390 | 2026-03-16 |
| 04046955638499 | ACCEL® | 613902 | 613902 | 2024-05-12 |
| 04046955638475 | ACCEL® | 613901 | 613901 | 2024-05-12 |
| 04046955638406 | ACCEL® | 613903 | 613903 | 2024-05-12 |
| 04046955638529 | ACCEL® | 613904 | 613904 | 2024-05-12 |
| 04046955638543 | ACCEL® | 613905 | 613905 | 2024-05-12 |
| 04046955638567 | ACCEL® | 613906 | 613906 | 2024-05-12 |
| 04046955638581 | ACCEL® | 613907 | 613907 | 2024-05-12 |
| 04046955638604 | ACCEL® | 613908 | 613908 | 2024-05-12 |
| 04046955638628 | ACCEL® | 613909 | 613909 | 2024-05-12 |
| 04046955638642 | ACCEL® | 613910 | 613910 | 2024-05-12 |
| 04046955638666 | ACCEL® | 613911 | 613911 | 2024-05-12 |
| 04046955638680 | ACCEL® | 613912 | 613912 | 2024-05-12 |
| 04046955638703 | ACCEL® | 613913 | 613913 | 2024-05-12 |
| 04046955638727 | ACCEL® | 613914 | 613914 | 2024-05-12 |
| 04046955638741 | ACCEL® | 613915 | 613915 | 2024-05-12 |
| 04046955638765 | ACCEL® | 613916 | 613916 | 2024-05-12 |
| 04046955638789 | ACCEL® | 613917 | 613917 | 2024-05-12 |
| 04046955638802 | ACCEL® | 613918 | 613918 | 2024-05-12 |
| 04046955638826 | ACCEL® | 613919 | 613919 | 2024-05-12 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07640119558639 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558646 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558653 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558660 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558677 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558684 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558691 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558707 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558714 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558721 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558738 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558745 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558752 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558769 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558776 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558783 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558790 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558806 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558813 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558820 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558837 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558844 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558851 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558868 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558875 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558882 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558899 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558905 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558912 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |
| 07640119558929 | Passeo-18 | Biotronik AG | LIT | 2016-08-24 |