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Labsystem™ Pro M00420020300

by Boston Scientific

Labsystem™ Pro M00420020300 is a Class I device made by Boston Scientific, listed in FDA GUDID since 23 May 2018 (UDI-DI 08714729884002), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08714729884002 UDI-DI Date23 May 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Labsystem™ Pro
Generic name
Cardiopulmonary physiological parameter analysis software, professional-only
Model / reference
M00420020300
Primary DI / UDI-DI
08714729884002
FDA product code
OUG
GMDN term
Cardiopulmonary physiological parameter analysis software, professional-only
Device class
Class I
Regulation number
880.6310
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiopulmonary physiological parameter analysis software

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)