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ivWatch Patient Monitor Model 400

by Ivwatch, LLC 3 variants

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 Number00814088020092 UDI-DI Date11 Jul 2017ListedStatusListed 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  • Withdrawn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
ivWatch Patient Monitor
Generic Name
Intravenous access site infiltration/extravasation monitoring system monitor
Model / Ref / Catalog
Model 400, 00814088020092
Primary DI / UDI-DI
00814088020092
FDA Product Code
PMS
GMDN Term
Intravenous access site infiltration/extravasation monitoring system monitor
Device Class
Class II
Regulation Number
880.5725
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Weight — 2.5 Pound
Depth — 2.63 Inch
Width — 6.14 Inch
Length — 8.0 Inch

Related devices

Category: Intravenous access site infiltration/extravasation monitoring system monitor

Other devices from Ivwatch, LLC

See all devices from Ivwatch, LLC →

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