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BD SmartSite

FDA UDI

Class II (US FDA UDI)

by BD Switzerland Sàrl

Identity

Trade Name
BD SmartSite FDA UDI
Generic Name
Basic intravenous administration set, noninvasive FDA UDI
Device Name
Gravity Set, Check Valve 4-Way Stopcock - 3 Ganged, 2 Needle-Free Valves, Vented/Nonvented 295 cm (116 in) FDA UDI
Model / Reference
42504E FDA UDI
Description
Gravity Set, Check Valve 4-Way Stopcock - 3 Ganged, 2 Needle-Free Valves, Vented/Nonvented 295 cm (116 in) FDA UDI

Identifiers

Catalog Number
42504E FDA UDI
Primary DI / UDI-DI
10885403235405 FDA UDI
FDA Product Code
FPA FDA UDI
LHI FDA UDI
GMDN Term
Basic intravenous administration set, noninvasive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Commercial Distribution
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

No

FDA UDI

Dimensions & Sizes

Size
Length — 116 Inch FDA UDI

Category: Basic intravenous administration set, noninvasive

BD SmartSite by BD Switzerland Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Basic intravenous administration set, noninvasive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BD Switzerland Sàrl

Sources (1)

  • FDA UDI d5fbf8eb-a1ce-447b-90af-77779f4a6bf8 37 fields · synced Jun 1, 2026