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Neonatal Single-Patient Nibp Cuffs
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803167541
Identity
- Trade Name
- NEONATAL SINGLE-PATIENT NIBP CUFFS EUDAMEDNIBP Cuffs FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- NIBP NeoSingle Patient Cuffs & Air Hoses EUDAMEDNeonatal Single-Patient NIBP Kit contains 50 Cuffs: 5 M1866B Size#1, 10 M1868B Size#2, 20 M1870B Size#3, 10 M1872B Size#4, 5 M1873B Size#5. Incorporates new connector configuration and replaces the M1820-60020. FDA UDI
- Model / Reference
- 989803167541 EUDAMEDNEONATAL SINGLE-PATIENT NIBP CUFFS FDA UDI
- Description
- Neonatal Single-Patient NIBP Kit contains 50 Cuffs: 5 M1866B Size#1, 10 M1868B Size#2, 20 M1870B Size#3, 10 M1872B Size#4, 5 M1873B Size#5. Incorporates new connector configuration and replaces the M1820-60020. FDA UDI
Identifiers
- Catalog Number
- 989803167541 FDA UDI
- Primary DI / UDI-DI
- 00884838008243 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM338T2 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
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
Neonatal Single-Patient Nibp Cuffs 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 f82b3c3c-f218-4f6c-bec9-030aa85454b3 61 fields · synced Jul 9, 2026
- FDA UDI 324c99d3-fd6a-46eb-960e-c5daebde7e8a 37 fields · synced May 30, 2026