Identity
- Trade Name
- FLEBOSET FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to cannel the solution from the source vials to the infusion set, and b) Pharmacy compounding when used in conjuntion with the Grifill pharmacy compounding device and associated transfers sets. Equipped with a spike on each line and a 0.2um hydrophobic air-filter, it minimizes teh formation of aerosols when preparing/dispensing the source substances. FDA UDI
- Model / Reference
- DOUBLE FDA UDI
- Description
- FLEBOSET DOUBLE is a disposable transfer set through which substances form 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to cannel the solution from the source vials to the infusion set, and b) Pharmacy compounding when used in conjuntion with the Grifill pharmacy compounding device and associated transfers sets. Equipped with a spike on each line and a 0.2um hydrophobic air-filter, it minimizes teh formation of aerosols when preparing/dispensing the source substances. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426314792578 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Fluid transfer set, general-purpose FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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
Fleboset by Laboratorios Grifols Sa — 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 |
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Manufacturer
- Manufacturer
- Laboratorios Grifols Sa
Sources (1)
- FDA UDI d6fb350b-b710-4102-b16e-931b20b60c3f 34 fields · synced Jun 1, 2026