SWAN-GANZ PACING TD CATHETER
- Primary DI
- 00690103197334
- Brand
- SWAN-GANZ PACING TD CATHETER
- Company
- Edwards Lifesciences LLC
- Model
- D205F7
- Catalog number
- D205F7
- Device description
- SWAN-GANZ PACING TD CATHETER
- Published
- 2018-12-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| LDF | Electrode, Pacemaker, Temporary |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LDF | Electrode, Pacemaker, Temporary | Cardiovascular | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00690103197334 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Temporary cardiac pacing balloon catheter | A sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device. |
Device Sizes
| Type | Value | Unit |
|---|
| Device Size Text, specify | 0 | |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store in a cool, dry place. |
Contacts
| Phone | Email |
|---|
| +1(800)822-9637 | tech_support@edwards.com |
Regulatory Flags
- DUNS number
- 134139174
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00690103019353 | AORTIC TRUE-SIZE OBTURATOR 19MM | 1161 | 116119MM | 2026-02-13 |
| 00690103019360 | AORTIC TRUE-SIZE OBTURATOR 21MM | 1161 | 116121MM | 2026-02-13 |
| 00690103019377 | AORTIC TRUE-SIZE OBTURATOR 23MM | 1161 | 116123MM | 2026-02-13 |
| 00690103019384 | AORTIC TRUE-SIZE OBTURATOR 25MM | 1161 | 116125MM | 2026-02-13 |
| 00690103019391 | AORTIC TRUE-SIZE OBTURATOR 27MM | 1161 | 116127MM | 2026-02-13 |
| 00690103019407 | AORTIC TRUE-SIZE OBTURATOR 29MM | 1161 | 116129MM | 2026-02-13 |
| 00690103019414 | AORTIC TRUE-SIZE OBTURATOR 31MM | 1161 | 116131MM | 2026-02-13 |
| 00690103019278 | HEART VALVE SIZER ACCESSORY | 1127 | 112723MM | 2026-02-11 |
| 00690103019285 | HEART VALVE SIZER ACCESSORY | 1127 | 112725MM | 2026-02-11 |
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