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Maxair 2500-27-Ir

by Syntech, Int'l Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K040485; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850078013132 UDI-DI Date26 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0835-2023 FDA Class II initiated 9 Nov 2022 on shared 510(k) K040485

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Maxair
Generic Name
Surgical helmet system
Model / Ref / Catalog
2500-27-IR
Primary DI / UDI-DI
00850078013132
510(k) Number
FDA Product Code
LYU
GMDN Term
Surgical helmet system
Device Class
Class I
Regulation Number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K040485)

Show all (10)

Other devices from Syntech, Int'l Inc.

See all devices from Syntech, Int'l Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

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
  • Serial Number: No
  • Expiration Date: No