FDA UDI
In Commercial Distribution
🇺🇸 United States
Z-6™
DI: 04046955718047
·
Model: 611050
·
B BRAUN INTERVENTIONAL SYSTEMS, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Z-6™
- Primary DI
- 04046955718047
- Version / Model
- 611050
- Catalog Number
- 611050
- Company Name
- B BRAUN INTERVENTIONAL SYSTEMS, INC
- Labeler DUNS
- 784259751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-09-04
- Public Version
- 3
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- a6c6c34a-82ab-4754-a6e5-dcfa5b660091
Device Description
Z695 Atrio Balloon Catheter 9.5mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXF | CATHETER, SEPTOSTOMY | Cardiovascular | 870.5175 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10747 | Cardiac septostomy catheter, balloon | A flexible tube with an inflatable balloon designed to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. This allows interatrial blood mixing in infants with transposition of the great vessels. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046955718047 | GS1 |
Customer Contacts
- Phone
- +1(877)836-2228
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211910 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter (mm) : 9.500 MM | ||
| Device Size Text, specify | Length : 9.500 MM | ||
| Device Size Text, specify | Length of catheter : 50.000 CM |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 20 – 22 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP AWAY FROM SUNLIGHT
- Type
- Special Storage Condition, Specify