Identity
- Trade Name
- SWAN-GANZ VIP FDA UDI
- Generic Name
- Pulmonary artery balloon catheter, electrical FDA UDI
- Device Name
- SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER FDA UDI
- Model / Reference
- 831F75 FDA UDI
- Description
- SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER FDA UDI
Identifiers
- Catalog Number
- 831F75P FDA UDI
- Primary DI / UDI-DI
- 00690103003031 FDA UDI
- FDA Product Code
- DYG FDA UDIDQO FDA UDIDQE FDA UDIKRA FDA UDIDQK FDA UDIDRS FDA UDIDSB FDA UDIDXN FDA UDIQAQ FDA UDI
- GMDN Term
- Pulmonary artery balloon catheter, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1240 FDA UDI870.1200 FDA UDI870.1230 FDA UDI870.1210 FDA UDI870.1425 FDA UDI870.2850 FDA UDI870.2770 FDA UDI870.1130 FDA UDI870.2210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Pulmonary artery balloon catheter, electrical
Swan-Ganz Vip by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K160084 also covers:
- SWAN-GANZ — Edwards Lifesciences LLC
- SWAN-GANZ — Edwards Lifesciences LLC
- SWAN-GANZ — Edwards Lifesciences LLC
- SWAN-GANZ — Edwards Lifesciences LLC
- SWAN-GANZ — Edwards Lifesciences LLC
- SWAN-GANZ — Edwards Lifesciences LLC
- SWAN-GANZ — Edwards Lifesciences LLC
- SWAN-GANZ CARDIOCATH TRUE SIZE — Edwards Lifesciences LLC
- SWAN-GANZ CCOMBO — Edwards Lifesciences LLC
- SWAN-GANZ CCOMBO — Edwards Lifesciences LLC
- SWAN-GANZ CCOMBO V — Edwards Lifesciences LLC
- SWAN-GANZ CONTROLCATH — Edwards Lifesciences LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI c0ba2e4c-c8ff-4353-a540-fb321d2dcfa1 38 fields · synced Jun 8, 2026