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Masimo Calibration Gas

by Airgas Therapeutics 13 variants

Listed FDA GUDID listing, no authorization on record

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 Number00819601025875 UDI-DI Date19 Dec 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Masimo
Generic Name
Calibration gas/refillable cylinder
Model / Ref / Catalog
Calibration Gas, Z03NI10K15A0000
Description
Description: 10% CO2, 80% N2O, BAL. N2; Cylinder: 150A; Valve: CGA 500; For calibration of medical analyzers in accordance with manufacturer's instructions.
Primary DI / UDI-DI
00819601025875
FDA Product Code
BXK
GMDN Term
Calibration gas/refillable cylinder
Device Class
Class I
Regulation Number
868.6400
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1659 Liter
Pressure — 605 Pound per Square Inch

Other devices from Airgas Therapeutics

See all devices from Airgas Therapeutics →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No