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Ultrasite®

FDA UDI

Class II (US FDA UDI)

by B. Braun Medical Inc.

Identity

Trade Name
ULTRASITE® FDA UDI
Generic Name
Positive-pressure intravenous line needleless valve-connector FDA UDI
Device Name
ULTRASITE® Luer Access Device FDA UDI
Model / Reference
415110 FDA UDI
Description
ULTRASITE® Luer Access Device FDA UDI

Identifiers

Catalog Number
415110 FDA UDI
Primary DI / UDI-DI
04022495769923 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Positive-pressure intravenous line needleless valve-connector 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

Category: Positive-pressure intravenous line needleless valve-connector

Ultrasite® by B. Braun Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Positive-pressure intravenous line needleless valve-connector.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
B. Braun Medical Inc.

Sources (1)

  • FDA UDI eaea4716-e4aa-4009-97cd-5ec4fef3da9f 35 fields · synced Jun 1, 2026