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Codonics Safe Label System®(SLS) 630i Point of Care Station - 170C 630i PCS

by Codonics Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number00814905021431 UDI-DI Date20 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Codonics Safe Label System®(SLS) 630i Point of Care Station - 170C
Generic Name
Anaesthesia unit, mobile
Model / Reference
630i PCS
Primary DI / UDI-DI
00814905021431
510(k) Number
FDA Product Code
BSZ
GMDN Term
Anaesthesia unit, mobile
Device Class
Class II
Regulation Number
868.5160
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251352)

Other devices from Codonics Inc.

See all devices from Codonics Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • 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
  • Expiration Date: No