SMARTFREEZE™
- Primary DI
- 00191506039677
- Brand
- SMARTFREEZE™
- Company
- BOSTON SCIENTIFIC CORPORATION
- Model
- M004CRBS5110
- Catalog number
- M004CRBS5110
- Device description
- Catheter Extension Cable
- 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
- true
- Single use
- true
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 |
|---|
| 00191506039677 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00191506039677 | 00191506039677 | 191506039677 | 0191506039677 |
GMDN Terms
| Term | Definition |
|---|
| Electrical-only medical device connection cable, single-use | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use 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
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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|---|
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| 00763000871925 | HexaPulse™ PF Generator | MEDTRONIC, INC. | OAE | 2024-11-04 |
| 00763000228699 | NA | MEDTRONIC, INC. | OAE | 2024-06-28 |
| 08714729992233 | INTELLANAV STABLEPOINT™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2024-02-29 |
| 08714729992240 | INTELLANAV STABLEPOINT™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2024-02-29 |
| 00763000709136 | DiamondTemp™ Catheter-to-RFG Cable | MEDTRONIC, INC. | OAE | 2024-01-12 |
| 00763000709150 | DiamondTemp™ Genconnect Cable | MEDTRONIC, INC. | OAE | 2024-01-12 |
| 00763000536671 | DiamondTemp™ Bidirectional Ablation Catheter | MEDTRONIC, INC. | OAE | 2023-12-30 |
| 00763000536688 | DiamondTemp™ Bidirectional Ablation Catheter | MEDTRONIC, INC. | OAE | 2023-12-30 |
| 00763000709198 | DiamondTemp™ Foot Switch | MEDTRONIC, INC. | OAE | 2023-12-16 |
| 00763000709181 | DiamondTemp™ Irrigation Tubing Set | MEDTRONIC, INC. | OAE | 2023-11-26 |
| 00763000709174 | DiamondTemp™ Irrigation Tubing Set | MEDTRONIC, INC. | OAE | 2023-11-26 |
| 00840216123014 | ASP MEDICAL | Asp Global, LLC | OAE | 2023-10-19 |
| 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 |
| 00191506039684 | SMARTFREEZE™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |
| 08714729992615 | POLARx™ | BOSTON SCIENTIFIC CORPORATION | OAE | 2023-08-21 |