Identity
- Trade Name
- Invasive Blood Pressure Module EUDAMEDIBP Module FDA UDI
- Generic Name
- Patient monitoring system module, blood pressure, invasive FDA UDI
- Device Name
- Invasive Pressure Module EUDAMEDInvasive Blood Pressure Module FDA UDI
- Model / Reference
- 862277 EUDAMEDInvasive Blood Pressure Module FDA UDI
- Description
- Invasive Blood Pressure Module FDA UDI
Identifiers
- Catalog Number
- 862277 FDA UDI
- Primary DI / UDI-DI
- 00884838020917 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00884838020917 EUDAMED
- FDA Product Code
- DRQ FDA UDI
- EMDN Code
- Z1203020301 INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
- GMDN Term
- Patient monitoring system module, blood pressure, invasive FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2060 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: In-line arterial blood sampling set
Invasive Blood Pressure Module by Philips Medizin Systeme Böblingen GmbH — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00884838020917 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Philips Medizin Systeme Böblingen GmbH
- EUDAMED SRN
- DE-MF-000006026
Sources (2)
- EUDAMED 296b09b7-ff10-4cf6-ba0a-21aa5f94da12 61 fields · synced Jul 9, 2026
- FDA UDI 4b06bd1d-6cd8-49c2-bc45-8e8ed44385cc 36 fields · synced May 29, 2026