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Vital Signs™ Pressure Infusor, 3000 mL, Netted, 12/CS
EUDAMEDFDA UDIClass I (EU MDR)
Ref IN950012-CEModel Vital Signs Pressure Infusor
by SunMed
Identity
- Trade Name
- Vital Signs™ Pressure Infusor, 3000 mL, Netted, 12/CS EUDAMEDVital Signs™ FDA UDI
- Generic Name
- Intravenous pressure infusor, manual, reusable FDA UDI
- Device Name
- Vital Signs™ Pressure Infusor FDA UDI
- Model / Reference
- Vital Signs Pressure Infusor EUDAMEDIN950012-CE EUDAMEDFDA UDI
- Description
- Vital Signs™ Pressure Infusor FDA UDI
Identifiers
- Catalog Number
- IN950012-CE FDA UDI
- Primary DI / UDI-DI
- 10889483642405 EUDAMEDFDA UDI
- Basic UDI-DI
- 0889483TF20012dPIBLH EUDAMED
- FDA Product Code
- KZD FDA UDI
- EMDN Code
- A080299 INFUSION BAGS AND CONTAINERS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Intravenous pressure infusor, manual, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3000 Milliliter FDA UDI
Vital Signs™ Pressure Infusor, 3000 mL, Netted, 12/CS by SunMed — 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 | 0889483TF20012dPIBLH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SunMed
- EUDAMED SRN
- US-MF-000009164
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 0338c403-14f6-4357-b65b-d48fb617e81f 61 fields · synced Oct 6, 2026
- FDA UDI 80ce5340-060b-4a6d-9848-bc4ea356cebe 37 fields · synced May 26, 2026