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PerforMax

by Respironics Inc. 31 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00606959014534 UDI-DI Date4 Mar 2019ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
CPAP/BPAP face mask, single-use
Model / Ref / Catalog
Performax Mask with EE, Leak 2, Single Use, XSmall, KR, 1119228
Primary DI / UDI-DI
00606959014534
FDA Product Code
BZD
GMDN Term
CPAP/BPAP face mask, single-use
Device Class
Class II
Regulation Number
868.5905
GUDID distribution status
Not in Commercial Distribution

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

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