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InnoSpire Mini

FDA UDI

Class II (US FDA UDI)

by Respironics Respiratory Drug Delivery (uk) Ltd

Identity

Trade Name
InnoSpire Mini FDA UDI
Generic Name
Therapeutic agent nebulizer, benchtop FDA UDI
Device Name
Innospire Mini with Battery (AUS), 6-pack FDA UDI
Model / Reference
00 FDA UDI
Description
Innospire Mini with Battery (AUS), 6-pack FDA UDI

Identifiers

Catalog Number
1111452 FDA UDI
Primary DI / UDI-DI
00383730002033 FDA UDI
510(k) Number
K060404 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
Not 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

No

FDA UDI

Over-the-Counter

Yes

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

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

Cleared under the same submission

K060404 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 f4e2f6dd-aff9-45eb-817f-9501b499fdc6 37 fields · synced Jun 1, 2026