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OBIX Perinatal Data System 9.1

by Clinical Computer Systems, 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 Number00868102000461 UDI-DI Date15 Jun 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  • Withdrawn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
OBIX Perinatal Data System
Generic Name
Patient health record information system application software
Model / Reference
9.1
Primary DI / UDI-DI
00868102000461
510(k) Number
FDA Product Code
HGM
GMDN Term
Patient health record information system application software
Device Class
Class II
Regulation Number
884.2740
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K121208)

Other devices from Clinical Computer Systems, Inc.

Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (12)

  • 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No