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Bicarbonate Liquid 09686223190

by Roche Diagnostics Corp. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613336223178 UDI-DIDate31 Aug 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Bicarbonate Liquid
Generic Name
Carbon dioxide (CO2) IVD, kit, spectrophotometry
Model / Ref / Catalog
09686223190
Primary DI / UDI-DI
07613336223178
510(k) Number
FDA Product Code
KHS
GMDN Term
Carbon dioxide (CO2) IVD, kit, spectrophotometry
Device Class
Class II
Regulation Number
862.1160
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K031879)

Other devices from Roche Diagnostics Corp.

See all devices from Roche Diagnostics Corp. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Expiration 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
  • Manufacturing Date: No