Identity
- Trade Name
- STRADIS FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- STERILE SEPARATE INTRODUCER 5F X 45CM FDA UDI
- Model / Reference
- 525-021 FDA UDI
- Description
- STERILE SEPARATE INTRODUCER 5F X 45CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- M7525250211 FDA UDI
- FDA Product Code
- DRE FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1310 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
- Lumen/Inner Diameter — 45 Centimeter FDA UDICatheter Gauge — 5 French FDA UDI
Stradis by Stradis Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stradis Medical, Llc
Sources (1)
- FDA UDI d3d675b2-fda6-4d09-b524-a3b0b7e9e777 36 fields · synced Jun 1, 2026