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InnoSpire Essence

FDA UDI

Class II (US FDA UDI)

by Respironics Respiratory Drug Delivery (uk) Ltd

Identity

Trade Name
InnoSpire Essence FDA UDI
Generic Name
Therapeutic agent nebulizer, benchtop FDA UDI
Device Name
Innospire Essence, Custom Focus Home Medical, 6-pack FDA UDI
Model / Reference
00 FDA UDI
Description
Innospire Essence, Custom Focus Home Medical, 6-pack FDA UDI

Identifiers

Catalog Number
1105185 FDA UDI
Primary DI / UDI-DI
00383730002224 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

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Therapeutic agent nebulizer, benchtop

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

Similar devices

Also classified as Therapeutic agent nebulizer, benchtop.

Cleared under the same submission

K042655 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Respironics Respiratory Drug Delivery (uk) Ltd

Sources (1)

  • FDA UDI dfc7fc62-6e6b-4b0b-a9bf-733d644d4bdf 36 fields · synced Jun 8, 2026