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N/A 2026031A

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 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 Number05030267151523 UDI-DI Date26 Mar 2017ListedStatusListed 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  • Withdrawn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

Generic Name
Ventilator breathing circuit, single-use
Model / Reference
2026031A
Primary DI / UDI-DI
05030267151523
510(k) Number
FDA Product Code
BZE
GMDN Term
Ventilator breathing circuit, single-use
Device Class
Class II
Regulation Number
868.5270
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 22 Millimeter
Length — 1.6 Meter

Related devices

Category: Ventilator breathing circuit, single-use

Cleared under the same submission (K092129)

Show all (12)

Other devices from Intersurgical Incorporated

See all devices from Intersurgical Incorporated →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number

Other properties (10)

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