Identity
- Trade Name
- NIBP Cuff Sample Kit (8 piece) EUDAMEDMR Patient Care NIBP Cuff Sample Kit (8 piece) FDA UDI
- Generic Name
- Blood pressure cuff, reusable FDA UDI
- Device Name
- Non-Invasive Blood Pressure Cuffs EUDAMEDNiBP Cuff, Single Lumen, Sample Kit,Disp. Includes 1 sample of each disposable NiBP cuff size. FDA UDI
- Model / Reference
- 989803182591 EUDAMEDNIBP Cuff Sample Kit (8 piece) FDA UDI
- Description
- NiBP Cuff, Single Lumen, Sample Kit,Disp. Includes 1 sample of each disposable NiBP cuff size. FDA UDI
Identifiers
- Catalog Number
- 989803182591 FDA UDI
- Primary DI / UDI-DI
- 10884838101279 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
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
NIBP Cuff Sample Kit (8 piece) by Invivo, a division of Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 fe45c073-91df-462e-ae7c-4b1a1d7ad9d4 61 fields · synced Jun 19, 2026
- FDA UDI 824da433-7094-4dd6-a374-c987f6375e01 37 fields · synced May 24, 2026