Altera

FDA UDI

Class II (US FDA UDI)

by Pari Respiratory Equipment, Inc.

Identity

Trade Name: Altera FDA UDI
Generic Name: Ultrasonic nebulizing system FDA UDI
Device Name: Altera Nebulizer System FDA UDI
Model / Reference: 678G1002 FDA UDI
Description: Altera Nebulizer System FDA UDI

Identifiers

Primary DI / UDI-DI: 00744229678021 FDA UDI
510(k) Number: K100380 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Ultrasonic nebulizing system 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Ultrasonic nebulizing system

Altera by Pari Respiratory Equipment, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K100380 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: Pari Respiratory Equipment, Inc.

Sources (1)

FDA UDI ae68c1e6-f4ce-4bf9-a86c-a611d03dc705 34 fields · synced May 30, 2026