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Stasis Labs Stasis Monitoring System

by Stasis Labs, 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 Number00854271008001 UDI-DI Date23 Oct 2019ListedStatusListed 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  • Withdrawn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
Stasis Labs
Generic Name
General-purpose multi-parameter bedside monitor
Model / Reference
Stasis Monitoring System
Primary DI / UDI-DI
00854271008001
510(k) Number
FDA Product Code
MWI
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class II
Regulation Number
870.2300
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Category: General-purpose multi-parameter bedside monitor

Other devices from Stasis Labs, Inc.

Properties

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