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BD PhaSeal

FDA UDI

Class II (US FDA UDI)

by BD Switzerland Sàrl

Identity

Trade Name
BD PhaSeal FDA UDI
Generic Name
Non-ISO80369-standardized fluid path protective cover FDA UDI
Device Name
Cap For Injector Membrane (M50) FDA UDI
Model / Reference
515404 FDA UDI
Description
Cap For Injector Membrane (M50) FDA UDI

Identifiers

Catalog Number
515404 FDA UDI
Primary DI / UDI-DI
00382905154041 FDA UDI
FDA Product Code
ONB FDA UDI
GMDN Term
Non-ISO80369-standardized fluid path protective cover 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

Yes

FDA UDI

Category: Luer/non-ISO80369-standardized linear connector, single-useNon-ISO80369-standardized fluid path protective cover

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

Similar devices

Also classified as Non-ISO80369-standardized fluid path protective cover.

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 6ea81e44-da4b-4ea3-8435-0f4ef611975a 35 fields · synced Jun 1, 2026