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Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense®
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Model / Reference
- AME-00202 HR US FDA UDI
Identifiers
- Catalog Number
- Hill-Rom PN 200898 FDA UDI
- Primary DI / UDI-DI
- 07290016169232 FDA UDI
- 510(k) Number
- K180079 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
Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® by Earlysense, Ltd. — Class II — FDA UDI — listed in FDA GUDID
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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
- Earlysense, Ltd.
Sources (1)
- FDA UDI 116cbc53-3dea-47c0-854e-ad0aa2464372 34 fields · synced May 30, 2026