Identity
- Trade Name
- NIBP Cuffs FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Model / Reference
- GENTLE CARE CUFF, LARGE ADULT XL, 1-TUBE FDA UDI
Identifiers
- Catalog Number
- M4578B FDA UDI
- Primary DI / UDI-DI
- 00884838009141 FDA UDI
- FDA Product Code
- OED FDA UDI
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1120 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood pressure cuff, reusable
NIBP Cuffs by Philips Medical Systems Hsg — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Welch Allyn, Inc. — Welch Allyn, 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
- Philips Medical Systems Hsg
Sources (1)
- FDA UDI 9cb458f0-fa9c-427b-bf99-0d3929217d03 35 fields · synced Jun 8, 2026