Prevantics® Device Swab Strip

FDA UDI

Class U (US FDA UDI)

by Professional Disposables International, Inc.

Identity

Trade Name: Prevantics® Device Swab Strip FDA UDI
Generic Name: Medical device cleaning/disinfection wipe FDA UDI
Device Name: Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs. FDA UDI
Model / Reference: B123ST FDA UDI
Description: Pre-moistened swabs to disinfect needleless access sites prior to use. Strip of 8 swabs. FDA UDI

Identifiers

Catalog Number: B123ST FDA UDI
Primary DI / UDI-DI: 00310819001779 FDA UDI
510(k) Number: K132380 FDA UDI
FDA Product Code: LKB FDA UDI
GMDN Term: Medical device cleaning/disinfection wipe FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 0.034 Fluid Ounce FDA UDI

Category: Medical device cleaning/disinfection wipe

Prevantics® Device Swab Strip by Professional Disposables International, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K132380 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Professional Disposables International, Inc.

Sources (1)

FDA UDI dd417768-f15d-44b1-9acc-a2eda28f394a 38 fields · synced Jun 8, 2026