SMARTFREEZE™
- Primary DI
- 08714729992783
- Brand
- SMARTFREEZE™
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M004CRBS6110
- Catalog number
- M004CRBS6110
- Device description
- Diaphragm Movement Sensor
- Published
- 2023-08-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | Unknown | 3 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| P220032 | 000 | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories | Boston Scientific Corporation | 2023-08-08 | OAE |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 08714729992783 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 08714729992783 | 08714729992783 | 8714729992783 |
GMDN Terms
| Term | Definition |
|---|
| Cardiac ablation thoracic motion sensor | A small electronic device intended to be placed on a patient’s chest during a cardiac ablation procedure to sense diaphragmatic movement as a means to assess potential phrenic nerve damage. It is intended to be used in conjunction with a separate monitor and senses motion based on accelerometery; it does not include any patient electrodes. This is a reusable device. |
Regulatory Flags
- DUNS number
- 021717889
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 08714729992752 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-09-29 |
| 08714729992714 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-09-25 |
| 08714729992721 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-09-25 |
| 08714729997481 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-09-25 |
| 00191506007737 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |
| 00191506015701 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |
| 00191506016463 | POLARx™ FIT | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |
| 00191506039677 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |
| 00191506039684 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |