Identity
- Trade Name
- Infant NBP Cuff EUDAMEDMR Patient Care Infant NBP Cuff FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Non-Invasive Blood Pressure Cuffs EUDAMEDNiBP Cuff, Single Lumen, Infant FDA UDI
- Model / Reference
- 989803182611 EUDAMEDInfant NBP Cuff FDA UDI
- Description
- NiBP Cuff, Single Lumen, Infant FDA UDI
Identifiers
- Catalog Number
- 989803182611 FDA UDI
- Primary DI / UDI-DI
- 00884838101289 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM456T9 EUDAMED
- FDA Product Code
- DXN FDA UDI
- EMDN Code
- Z1203020299 MULTI–PARAMETER MONITORS - OTHER EUDAMED
- GMDN Term
- Blood pressure cuff, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1130 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
No
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
MR Safe FDA UDI
Infant NBP Cuff by Invivo, a division of 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 | 0884838BM456T9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Invivo, a division of Philips Medical Systems
- EUDAMED SRN
- US-MF-000002177
- Authorised Representative
- Philips Medizin Systeme Böblingen GmbH DE-AR-000006030
Sources (2)
- EUDAMED 8af9f290-9f45-43b7-8c73-752570dcf6b6 61 fields · synced Oct 6, 2026
- FDA UDI 7570f121-bc4b-48dc-94ab-f01ebd5730c3 37 fields · synced May 29, 2026