Neonatal Single-Patient Nibp Cuffs
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- NEONATAL SINGLE-PATIENT NIBP CUFFS EUDAMEDNIBP Cuffs FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Neonatal Single & Soft-Single NIBP Cuffs 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
- Neonatal Single & Soft-Single NIBP Cuffs EUDAMED989803167541 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
- 00884838114913 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM1842MZ 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
No
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 — 15.000 Centimeter FDA UDICircumference — 13.100 Centimeter FDA UDICircumference — 10.900 Centimeter FDA UDICircumference — 8.000 Centimeter FDA UDICircumference — 5.700 Centimeter FDA UDI
Category: General-purpose multi-parameter bedside monitor
Neonatal Single-Patient Nibp Cuffs by Philips Medizin Systeme Böblingen GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as General-purpose multi-parameter bedside monitor.
- SpO2 Adapter cable — Orantech Inc. · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- Flying-V cuff LARGE — CNSystems Medizintechnik GmbH · Class II
- Expression MR200 Accessories — Philips DS North America LLC · Class II
- IBP Adapter Cable — Orantech Inc. · Class I
- LiDCO — LIDCO LIMITED · Class II
- LiDCO — LIDCO LIMITED · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 2c3cbb28-6732-41c1-8a87-e3ec2091265a 61 fields · synced Jul 24, 2026
- FDA UDI f67d9532-b7d4-4d33-b3ff-4e21fc7f5521 36 fields · synced May 29, 2026