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Bard® Lopez Valve® with ENFit™

FDA UDI

Class II (US FDA UDI)

by C. R. Bard, Inc.

Identity

Trade Name
Bard® Lopez Valve® with ENFit™ FDA UDI
Generic Name
Luer/Luer linear connector, single-use FDA UDI
Device Name
Bard® Lopez Valve® with ENFit™ FDA UDI
Model / Reference
EN0056000 FDA UDI
Description
Bard® Lopez Valve® with ENFit™ FDA UDI

Identifiers

Catalog Number
EN0056000 FDA UDI
Primary DI / UDI-DI
00801741113901 FDA UDI
510(k) Number
K915171 FDA UDI
FDA Product Code
KNT FDA UDI
GMDN Term
Luer/Luer linear connector, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Bard® Lopez Valve® with ENFit™ by C. R. Bard, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K915171 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
C. R. Bard, Inc.

Sources (1)

  • FDA UDI 02577b48-b79d-4015-a0b2-f0949b0c290b 37 fields · synced May 31, 2026