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: Nebulizer Connection Cord FDA UDI
Model / Reference: 178F6009 FDA UDI
Description: Nebulizer Connection Cord FDA UDI

Identifiers

Primary DI / UDI-DI: 00744229178026 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

FDA UDI

Over-the-Counter

Yes

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: 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 33376818-fc2e-4141-b6b0-2fe494a48019 34 fields · synced May 30, 2026