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Neo Delta Self Safe 1 26G 19mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3708122Model Safety Peripheral IV catheters
Identity
- Trade Name
- Neo Delta Self Safe 1 26G 19mm EUDAMEDNeo Delta Self Safe® FDA UDI
- Generic Name
- Peripheral vascular catheter FDA UDI
- Device Name
- Neo Delta Self Safe 1 FDA UDI
- Model / Reference
- Safety Peripheral IV catheters EUDAMED3708122 EUDAMEDFDA UDI
- Description
- Neo Delta Self Safe 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08032248000551 EUDAMED08032248370814 FDA UDI
- Basic UDI-DI
- 8032248000026F EUDAMED
- Direct Marketing DI
- 08032248000551 EUDAMED
- FDA Product Code
- FOZ FDA UDI
- EMDN Code
- C0101010202 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, W/O INJECTION VALVES EUDAMED
- GMDN Term
- Peripheral vascular catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 19 Millimeter FDA UDIOuter Diameter — 0.64 Millimeter FDA UDI
Neo Delta Self Safe 1 26G 19mm by Delta Med Spa — Class IIa — 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 | 8032248000026F | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Delta Med SPA
- EUDAMED SRN
- IT-MF-000027962
Sources (2)
- EUDAMED 72a34bc0-7fe0-4f75-813d-fe17eba82552 61 fields · synced Aug 1, 2026
- FDA UDI 38358cff-9a25-4e10-b4e1-f56f9a17efb1 34 fields · synced May 30, 2026