Identity
- Trade Name
- VOLUMEVIEW FDA UDI
- Generic Name
- Invasive-pressure external transducer, single-use FDA UDI
- Device Name
- VOLUMEVIEW SENSOR,84",5P,RED C FDA UDI
- Model / Reference
- VLV8R5 FDA UDI
- Description
- VOLUMEVIEW SENSOR,84",5P,RED C FDA UDI
Identifiers
- Catalog Number
- VLV8R5 FDA UDI
- Primary DI / UDI-DI
- 07460691950481 FDA UDI
- FDA Product Code
- KRB FDA UDIDRS FDA UDI
- GMDN Term
- Invasive-pressure external transducer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1915 FDA UDI870.2850 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
No
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 Conditional FDA UDI
Category: Invasive-pressure external transducer, single-use
Volumeview 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
K100739 also covers:
- 1-FEMORAL CATHETER KIT (5F, 20 CM), SINGLE PACK — Edwards Lifesciences LLC
- VOLUMEVIEW — Edwards Lifesciences LLC
- VOLUMEVIEW — Edwards Lifesciences LLC
- VOLUMEVIEW — Edwards Lifesciences LLC
- VOLUMEVIEW — Edwards Lifesciences LLC
- VOLUMEVIEW — Edwards Lifesciences LLC
- VOLUMEVIEW — Edwards Lifesciences LLC
- VOLUMEVIEW — Edwards Lifesciences LLC
- VOLUMEVIEW — Edwards Lifesciences LLC
- VolumeView — Edwards Lifesciences LLC
- VolumeView — Edwards Lifesciences LLC
- VolumeView — Edwards Lifesciences LLC
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- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
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- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
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- ACUMEN IQ SENSOR FOR AFM — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
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- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI a39bf0e5-d528-404d-a14b-dc08a1fc7655 38 fields · synced Jun 8, 2026