FDA UDI
In Commercial Distribution
🇺🇸 United States
DiamondTemp™ Bidirectional Ablation Catheter
DI: 00763000482121
·
Model: CEDTB300S
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DiamondTemp™ Bidirectional Ablation Catheter
- Primary DI
- 00763000482121
- Version / Model
- CEDTB300S
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-21
- Public Version
- 1
- Public Version Date
- 2021-10-29
- Public Version Status
- New
- Public Device Record Key
- ad0ec1a7-cc27-45af-8459-d576ab867c87
Device Description
CATH CEDTB300S BIDIR SM CURVE US
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61785 | Cardiac radio-frequency ablation system catheter | A sterile, flexible, steerable catheter intended to be used as part of a radio-frequency cardiac ablation system to apply radio-frequency alternating current to ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias; it is typically also intended to transmit electrical pacing stimuli to, and electrical responses from, the heart for electrophysiological (EP) mapping. It is intended to be introduced into the heart via venous access (e.g., femoral vein) and may contain monopolar and/or bipolar ablation electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000482121 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200028 | 006 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Electrode spacing between distal electrode and proximal electrode .5mm | ||
| Device Size Text, specify | Electrode spacing between composite electrode and distal ring electrode 3.5mm | ||
| Device Size Text, specify | Composite tip electrode length 4.1mm | ||
| Tip Bend Radius | 45.0 | Millimeter | |
| Outer Diameter | 2.67 | Millimeter | |
| Catheter Length | 110.0 | Centimeter | |
| Device Size Text, specify | Catheter tip size 2.50mm (7.5Fr) | ||
| Device Size Text, specify | Ring electrode length 1.3mm | ||
| Device Size Text, specify | Distal electrode length .6mm | ||
| Device Size Text, specify | Electrode spacing between distal ring electrode and proximal ring electrode 2mm |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- -22 – 140 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight