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InnoSpire Elegance 00

by Respironics Respiratory Drug Delivery (UK) Ltd 121 variants

Listed FDA GUDID listing, no authorization on record

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 Number00383730001791 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: 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  • Withdrawn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, 1102463
Primary DI / UDI-DI
00383730001791
510(k) Number
FDA Product Code
BTI
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class II
Regulation Number
868.6250
GUDID distribution status
In Commercial Distribution

Related devices

Category: Therapeutic agent nebulizer, benchtop

Cleared under the same submission (K042655)

Show all (12)

Other devices from Respironics Respiratory Drug Delivery (UK) Ltd

See all devices from Respironics Respiratory Drug Delivery (UK) Ltd →

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number

Other properties (11)

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