Identity
- Trade Name
- Classic Infusor 3000 / 5000 ml EUDAMEDClassic Infusor FDA UDI
- Generic Name
- Intravenous pressure infusor, manual, reusable FDA UDI
- Device Name
- Pressure Infusion Cuffs - Classic Infusor EUDAMED3000 / 5000 ml FDA UDI
- Model / Reference
- 58-01-300 EUDAMEDFDA UDI
- Description
- 3000 / 5000 ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14250105629368 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-2.6.1-W7 EUDAMED
- Direct Marketing DI
- 04250105629361 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 3000 Milliliter FDA UDITotal Volume — 5000 Milliliter FDA UDI
Category: Intravenous administration bag/bottle
Classic Infusor 3000 / 5000 ml by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 42501056-2.6.1-W7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- VBM Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000005907
Sources (2)
- EUDAMED aed862e1-c450-4e90-a54a-135bbd5950d1 61 fields · synced Jun 18, 2026
- FDA UDI 7bd04739-2ead-406a-b243-87703a6892d5 36 fields · synced May 30, 2026