100NX DUO Upgrade Kit with VELOCITY

FDA UDI

Class II (US FDA UDI)

by Advanced Sterilization Products Services Inc.

Identity

Trade Name: 100NX DUO Upgrade Kit with VELOCITY FDA UDI
Generic Name: Plasma sterilizer FDA UDI
Device Name: 100NX DUO Upgrade Kit with VELOCITY FDA UDI
Model / Reference: 10137V FDA UDI
Description: 100NX DUO Upgrade Kit with VELOCITY FDA UDI

Identifiers

Catalog Number: 10137V FDA UDI
Primary DI / UDI-DI: 10705037068173 FDA UDI
510(k) Number: K013003 FDA UDI
K111377 FDA UDI
FDA Product Code: MLR FDA UDI
FRG FDA UDI
GMDN Term: Plasma sterilizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6860 FDA UDI
880.6850 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

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Instrument tray, reusable Plasma sterilizer

100NX DUO Upgrade Kit with VELOCITY by Advanced Sterilization Products Services Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K111377 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 II	Pending data

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Manufacturer

Manufacturer: Advanced Sterilization Products Services Inc.

Sources (1)

FDA UDI fad8a3c2-cf36-463a-90b0-84cd55c98360 37 fields · synced May 30, 2026