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InnoSpire Elegance 00

by Respironics Respiratory Drug Delivery (UK) Ltd 121 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00383730002828 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
InnoSpire Elegance
Generic Name
Therapeutic agent nebulizer, benchtop
Model / Ref / Catalog
00, 1120563
Primary DI / UDI-DI
00383730002828
510(k) Number
FDA Product Code
BTI
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class II
Regulation Number
868.6250
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K042655)

Show all (12)

Other devices from Respironics Respiratory Drug Delivery (UK) Ltd

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No