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Heart and Respiration Rate Monitoring System powered by EarlySense
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Heart and Respiration Rate Monitoring System powered by EarlySense FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- EarlySense Sensor Assembly FDA UDI
- Model / Reference
- P200898 FDA UDI
- Description
- EarlySense Sensor Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887761985155 FDA UDI
- FDA Product Code
- BZQ FDA UDI
- GMDN Term
- Patient monitoring system module, multifunction FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 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
No
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
MR Unsafe FDA UDI
Category: Patient monitoring system module, multifunction
Heart and Respiration Rate Monitoring System powered by EarlySense by Hill-Rom, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Hill-Rom, Inc.
Sources (1)
- FDA UDI 9db609e7-8d83-4656-a8f1-cd6f24217a51 34 fields · synced Jun 1, 2026