Identity
- Trade Name
- EV1000 FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
- Device Name
- EV1000 MONITOR FDA UDI
- Model / Reference
- EV1000M FDA UDI
- Description
- EV1000 MONITOR FDA UDI
Identifiers
- Catalog Number
- EV1000M FDA UDI
- Primary DI / UDI-DI
- 00690103190106 FDA UDI
- FDA Product Code
- DSB FDA UDIDXN FDA UDIDXG FDA UDI
- GMDN Term
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2770 FDA UDI870.1130 FDA UDI870.1435 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose multi-parameter bedside monitorPatient monitoring system module, blood pressure, noninvasivePatient positioning sensor
Ev1000 by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient positioning sensor.
- NGENIUS — Stryker Leibinger · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
- V40 — MAKO Surgical Corp. · Class II
- Patient tracker EM-D mini — Scopis GmbH · Class II
- General Purpose Sensor — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
- Calibration End Effector Inverted — MAKO Surgical Corp. · Class II
- Sherlock — Bard Access Systems, Inc. · Class II
Cleared under the same submission
K131892 also covers:
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- FLOTRAC — Edwards Lifesciences LLC
- FLOTRAC — Edwards Lifesciences LLC
K140312 also covers:
- CLEARSIGHT — Edwards Lifesciences LLC
- CLEARSIGHT — Edwards Lifesciences LLC
- CLEARSIGHT — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
K160552 also covers:
- CLEARSIGHT — Edwards Lifesciences LLC
- CLEARSIGHT — Edwards Lifesciences LLC
- CLEARSIGHT — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — Edwards Lifesciences LLC
- EV1000 — 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 e14ef4df-f913-4751-b351-5a7fb90d3456 38 fields · synced Jun 8, 2026