Neonatal Single-Patient Cuff Size #3
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- NEONATAL SINGLE-PATIENT CUFF SIZE #3 EUDAMEDNIBP Cuffs FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Neonatal Single & Soft-Single NIBP Cuffs EUDAMEDNeonatal Soft Single-Patient Cuff Size#2 FDA UDI
- Model / Reference
- Neonatal Single & Soft-Single NIBP Cuffs EUDAMEDM1870B 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
- 20884838114979 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1842MZ EUDAMED
- Unit of Use DI
- 00884838114975 EUDAMED
- FDA Product Code
- DXQ FDA UDI
- EMDN Code
- Z1203020285 MULTI-PARAMETER MONITORS - CONSUMABLES 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Circumference — 8.000 Centimeter FDA UDI
Category: General-purpose multi-parameter bedside monitor
Neonatal Single-Patient Cuff Size #3 by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM1842MZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 4735dd9a-93a0-43ac-84ac-49ae7bab1af2 61 fields · synced Jul 16, 2026
- FDA UDI 26d218ef-e17d-4070-a12b-51cb82b90015 36 fields · synced May 30, 2026