Identity
- Trade Name
- Adult-Long NBP Cuffs (10) EUDAMEDMR Patient Care Adult-Long NBP Cuffs (10) FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Non-Invasive Blood Pressure Cuffs EUDAMEDNiBP Cuff, Single Lumen, Adult-L, Disp. Box of 10 FDA UDI
- Model / Reference
- 989803182551 EUDAMEDAdult-Long NBP Cuffs (10) FDA UDI
- Description
- NiBP Cuff, Single Lumen, Adult-L, Disp. Box of 10 FDA UDI
Identifiers
- Catalog Number
- 989803182551 FDA UDI
- Primary DI / UDI-DI
- 10884838101231 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM456T9 EUDAMED
- Unit of Use DI
- 00884838101234 EUDAMED
- FDA Product Code
- DXN 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
- 870.1130 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Category: General-purpose multi-parameter bedside monitor
Adult-Long NBP Cuffs (10) by Invivo, a division of Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as General-purpose multi-parameter bedside monitor.
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- LiDCO — LIDCO LIMITED · Class II
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 35216f22-a2d5-46ed-b655-10c04ceb0141 61 fields · synced Oct 6, 2026
- FDA UDI adffafe1-ae4b-48a5-a386-c47c42a0456a 37 fields · synced May 25, 2026