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True Integral MY-131B

by True Integral Inc

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 Number00860015383938 UDI-DI Date31 Mar 2026ListedStatusListed 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  • Withdrawn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

Trade Name
True Integral
Generic Name
Nebulizing system delivery set, reusable
Model / Reference
MY-131B
Primary DI / UDI-DI
00860015383938
510(k) Number
FDA Product Code
CAF
GMDN Term
Nebulizing system delivery set, reusable
Device Class
Class II
Regulation Number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K201397)

Other devices from True Integral Inc

See all devices from True Integral Inc →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No