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Nexus NIS®

FDA UDI

Class II (US FDA UDI)

by Nexus Medical, LLC

Identity

Trade Name
Nexus NIS® FDA UDI
Generic Name
Vial transfer spike FDA UDI
Device Name
Non-Vented Vial Access Spike with Nexus NIS®-6P FDA UDI
Model / Reference
N0650 FDA UDI
Description
Non-Vented Vial Access Spike with Nexus NIS®-6P FDA UDI

Identifiers

Primary DI / UDI-DI
10815879020830 FDA UDI
510(k) Number
K080976 FDA UDI
FDA Product Code
LHI FDA UDI
GMDN Term
Vial transfer spike 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: Vial transfer spike

Nexus NIS® by Nexus Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vial transfer spike.

Cleared under the same submission

K080976 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nexus Medical, LLC

Sources (1)

  • FDA UDI 76321a77-08cf-48c7-8553-41165f178edd 35 fields · synced Jun 1, 2026