Identity
- Trade Name
- COMFORT CARE CUFF, INFANT EUDAMEDNIBP Cuffs FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Comfort Care NIBP Cuffs EUDAMEDLong-life reusable NIBP cuff/infant Premium quality individual cuff w/fluid cap & instructions; limb circumference 10.0-15cm. Polyurethane bladder, hose, cover. No latex or PVC. FDA UDI
- Model / Reference
- M1571A EUDAMEDCOMFORT CARE CUFF, INFANT FDA UDI
- Description
- Long-life reusable NIBP cuff/infant Premium quality individual cuff w/fluid cap & instructions; limb circumference 10.0-15cm. Polyurethane bladder, hose, cover. No latex or PVC. FDA UDI
Identifiers
- Catalog Number
- M1571A FDA UDI
- Primary DI / UDI-DI
- 00884838001541 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM333SQ EUDAMED
- FDA Product Code
- DSI FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 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
Dimensions & Sizes
- Size
- Circumference — 15 Centimeter FDA UDI
Comfort Care Cuff, Infant 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 | 0884838BM333SQ | 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 192b4019-1236-4ce7-a0c9-2017b8bd18e8 61 fields · synced Jul 15, 2026
- FDA UDI 4df1eb7b-3598-4b0b-bb0b-a58f575cfb25 38 fields · synced May 30, 2026