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Neonatal Soft Single-Patient Cuff Size#2
EUDAMEDFDA UDIClass I (EU MDR)
Ref M1868S
Identity
- Trade Name
- NEONATAL SOFT SINGLE-PATIENT CUFF SIZE#2 EUDAMEDNIBP Cuffs FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- NIBP NeoSingle Patient Cuffs & Air Hoses EUDAMEDNeonatal Soft Single-Patient Cuff Size#2 FDA UDI
- Model / Reference
- M1868S EUDAMEDNEONATAL SOFT SINGLE-PATIENT CUFF SIZE#2 FDA UDI
- Description
- Neonatal Soft Single-Patient Cuff Size#2 FDA UDI
Identifiers
- Catalog Number
- M1868S FDA UDI
- Primary DI / UDI-DI
- 20884838008520 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM338T2 EUDAMED
- Unit of Use DI
- 00884838008526 EUDAMED
- FDA Product Code
- DXQ 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
- 870.1120 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Circumference — 8 Centimeter FDA UDI
Neonatal Soft Single-Patient Cuff Size#2 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 | 0884838BM338T2 | 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 45609911-0213-41f5-a66c-7f5d93be2ec9 61 fields · synced Jun 18, 2026
- FDA UDI 7c299d99-72d7-40e8-bb1f-d16b96510fc4 38 fields · synced May 30, 2026