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Redsense Alarm System North America charger 1

by Redsense Medical AB (publ)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350078030137 UDI-DI Date16 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Redsense Alarm System North America charger
Generic Name
Intravenous access site line-disconnection monitoring system
Model / Ref / Catalog
1, RC-1-RC201-C
Primary DI / UDI-DI
07350078030137
510(k) Number
FDA Product Code
ODX
GMDN Term
Intravenous access site line-disconnection monitoring system
Device Class
Class II
Regulation Number
876.5820
GUDID distribution status
In Commercial Distribution
Size
Weight — 161 Gram

Related devices

Cleared under the same submission (K130554)

Other devices from Redsense Medical AB (publ)

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No