SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
FDA 510(k)Class II (US FDA 510(k))
by Gilero, LLC
Identifiers
- 510(k) Number
- K201936 FDA 510(k)
- FDA Product Code
- KPE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5025 FDA 510(k)
- Regulation Number
- 880.5025 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is an I.V. container, as defined by its device type and nomenclature authority. It is designed for the collection, storage, and administration of intravenous fluids in a clinical setting.
The SmartSite Bag is supplied in three sizes: 500mL, 250 mL, and 100 mL. It is a single-use device, cleared via FDA 510(k) under product code KPE and regulation number 880.5025, and is intended for use in general hospital environments.
Frequently asked questions
What is the SmartSite Bag used for?
The SmartSite Bag is an I.V. container designed for the collection, storage, and administration of intravenous fluids in clinical settings. It is available in three sizes: 500mL, 250mL, and 100mL to accommodate different fluid volume requirements.
Is the SmartSite Bag reusable or single-use?
The SmartSite Bag is a single-use device, meaning it should be discarded after one use. This design helps prevent cross-contamination between patients and ensures sterility for each administration.
What regulatory approvals does the SmartSite Bag have?
The SmartSite Bag is cleared via FDA 510(k) under product code KPE and regulation number 880.5025. It has been determined to be substantially equivalent to other legally marketed I.V. containers for use in general hospital environments.
How is the SmartSite Bag supplied?
The SmartSite Bag is supplied in three different sizes: 500mL, 250mL, and 100mL. Each size is designed to meet specific clinical needs for fluid administration, storage, and collection in hospital settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201936 | Class II | Active |
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Manufacturer
- Manufacturer
- Gilero, LLC
Sources (1)
- FDA 510(k) K201936 24 fields · synced Oct 6, 2026