Identity
- Trade Name
- ACUMEN IQ SENSOR FDA UDI
- Generic Name
- Invasive-pressure external transducer, single-use FDA UDI
- Device Name
- ACUMEN IQ SENSOR W/ VAMP ADULT 60"/152cm 5-Pack FDA UDI
- Model / Reference
- AIQS6AZ5 FDA UDI
- Description
- ACUMEN IQ SENSOR W/ VAMP ADULT 60"/152cm 5-Pack FDA UDI
Identifiers
- Catalog Number
- AIQS6AZ5 FDA UDI
- Primary DI / UDI-DI
- 00690103200980 FDA UDI
- 510(k) Number
- K152980 FDA UDI
- FDA Product Code
- DRS FDA UDI
- GMDN Term
- Invasive-pressure external transducer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2850 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
No
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
Dimensions & Sizes
- Size
- Length — 60 Inch FDA UDI
Category: Invasive-pressure external transducer, single-use
Acumen Iq Sensor 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
K152980 also covers:
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR — Edwards Lifesciences LLC
- ACUMEN IQ SENSOR FOR AFM — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- Acumen IQ — Edwards Lifesciences LLC
- 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 |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
Sources (1)
- FDA UDI 7f443d48-0ce5-4f36-849c-77c3554aeb65 38 fields · synced Jun 8, 2026