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N/A RM21318

by Intersurgical Incorporated

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 Number00619498213184 UDI-DI Date17 Sep 2015ListedStatusListed 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  • Withdrawn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

Generic Name
Ventilator breathing circuit, single-use
Model / Reference
RM21318
Primary DI / UDI-DI
00619498213184
510(k) Number
FDA Product Code
CBP
GMDN Term
Ventilator breathing circuit, single-use
Device Class
Class II
Regulation Number
868.5870
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 15 Millimeter
Length — 160 Centimeter

Related devices

Category: Ventilator breathing circuit, single-use

Cleared under the same submission (K132143)

Show all (12)

Other devices from Intersurgical Incorporated

See all devices from Intersurgical Incorporated →

Properties

  • Single Use
  • Prescription Use
  • Combination Product
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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