InnoSpire Elegance

FDA UDIEUDAMED

Class II (US FDA UDI)

by Respironics Respiratory Drug Delivery (uk) Ltd

Identity

Trade Name: InnoSpire Elegance FDA UDI
Generic Name: Therapeutic agent nebulizer, benchtop FDA UDI
Device Name: Innospire Elebance, Custom RTA, 6 pack. FDA UDI
Model / Reference: 00 FDA UDI
Description: Innospire Elebance, Custom RTA, 6 pack. FDA UDI

Identifiers

Catalog Number: 1105101 FDA UDI
Primary DI / UDI-DI: 00383730002644 FDA UDI
510(k) Number: K042655 FDA UDI
FDA Product Code: BTI FDA UDI
GMDN Term: Therapeutic agent nebulizer, benchtop FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.6250 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Therapeutic agent nebulizer, benchtop

InnoSpire Elegance by Respironics Respiratory Drug Delivery (uk) Ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Cleared under the same submission

K042655 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Respironics Respiratory Drug Delivery (uk) Ltd

Sources (2)

FDA UDI de8e819e-6d5b-4c3d-8a93-47d137888b5b 36 fields · synced Jun 19, 2026
EUDAMED 1 fields · synced May 29, 2026