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N/A RM21308

by Intersurgical Incorporated

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00619498213085 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Ventilator breathing circuit, single-use
Model / Reference
RM21308
Primary DI / UDI-DI
00619498213085
FDA Product Code
CAI
GMDN Term
Ventilator breathing circuit, single-use
Device Class
Class I
Regulation Number
868.5240
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 22 Millimeter
Length — 160 Centimeter

Related devices

Category: Ventilator breathing circuit, single-use

Other devices from Intersurgical Incorporated

See all devices from Intersurgical Incorporated →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No