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Gentle Care Cuff, Large Adult Xl, 1-Tube
EUDAMEDFDA UDIClass I (EU MDR)
Ref m4578b
Identity
- Trade Name
- GENTLE CARE CUFF, LARGE ADULT XL, 1-TUBE EUDAMEDNIBP Cuffs FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Easy Care Cuffs and Gentle Care Cuffs EUDAMEDGentle Care Cuff, Large Adult XL, 1-tube (burgandy with edge striping). Soft Single Patient. Circumference 35 - 45 cm. 10/box. FDA UDI
- Model / Reference
- m4578b EUDAMEDGENTLE CARE CUFF, LARGE ADULT XL, 1-TUBE FDA UDI
- Description
- Gentle Care Cuff, Large Adult XL, 1-tube (burgandy with edge striping). Soft Single Patient. Circumference 35 - 45 cm. 10/box. FDA UDI
Identifiers
- Catalog Number
- m4578b FDA UDI
- Primary DI / UDI-DI
- 20884838009145 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM339T4 EUDAMED
- Unit of Use DI
- 00884838009141 EUDAMED
- FDA Product Code
- OED FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1120 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Gentle Care Cuff, Large Adult Xl, 1-Tube by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM339T4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 4af1d999-fdc7-493b-9d1b-1a2023cb7216 61 fields · synced Oct 6, 2026
- FDA UDI 8e061853-a584-4146-90f3-b90dc212dcb7 37 fields · synced May 30, 2026