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Clinical Data and Visualization Application BOM000042

by Beta Bionics, Inc.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850050080466 UDI-DI Date8 Sep 2026ListedStatusListed 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  • Withdrawn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
Clinical Data and Visualization Application
Generic Name
Self-care monitoring/reporting software
Model / Ref / Catalog
BOM000042, BB1029
Primary DI / UDI-DI
00850050080466
FDA Product Code
PHV
GMDN Term
Self-care monitoring/reporting software
Device Class
Class I
Regulation Number
862.2120
GUDID distribution status
In Commercial Distribution

Other devices from Beta Bionics, Inc.

See all devices from Beta Bionics, Inc. →

Properties

  • Premarket Exempt

Other properties (13)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No