NebuTech®

FDA UDI

Class II (US FDA UDI)

by Salter Labs

Identity

Trade Name: NebuTech® FDA UDI
Generic Name: Therapeutic agent nebulizer, benchtop FDA UDI
Device Name: NebuTech® HDN® Nebulizer (Adult) with aerosol mask, 7’ (2.1 m) supply tube, over-the-ear fixation and mouthpiece with valve. FDA UDI
Model / Reference: 8964-7 FDA UDI
Description: NebuTech® HDN® Nebulizer (Adult) with aerosol mask, 7’ (2.1 m) supply tube, over-the-ear fixation and mouthpiece with valve. FDA UDI

Identifiers

Catalog Number: 8964-7 FDA UDI
Primary DI / UDI-DI: 00607411890468 FDA UDI
510(k) Number: K961476 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Therapeutic agent nebulizer, benchtop FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Therapeutic agent nebulizer, benchtop

NebuTech® by Salter Labs — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K961476 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: Salter Labs

Sources (1)

FDA UDI c6e230e0-1ecf-4820-ac3e-396dabda26f5 38 fields · synced Jun 8, 2026