Identity
- Trade Name
- EV1000 FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, noninvasive FDA UDI
- Device Name
- PRESSURE CONTROLLER KIT FDA UDI
- Model / Reference
- PC2K FDA UDI
- Description
- PRESSURE CONTROLLER KIT FDA UDI
Identifiers
- Catalog Number
- PC2K FDA UDI
- Primary DI / UDI-DI
- 00690103193473 FDA UDI
- FDA Product Code
- DSB FDA UDIDXN FDA UDIDQK FDA UDIQAQ 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 UDI870.1425 FDA UDI870.2210 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
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- Sherlock — Bard Access Systems, Inc. · Class II
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 877dad72-bc9c-46ae-b585-88095012afe1 37 fields · synced Jun 8, 2026