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eTube Disposable - Box of 20 6001

by Avails Medical, Inc.

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 Number10860007740012 UDI-DI Date23 Jul 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  • Withdrawn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
eTube Disposable - Box of 20
Generic Name
Assay container IVD, single-use
Model / Ref / Catalog
6001, US-EQTBE-020
Primary DI / UDI-DI
10860007740012
510(k) Number
FDA Product Code
QZX
GMDN Term
Assay container IVD, single-use
Device Class
Class II
Regulation Number
866.1650
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K231536)

Other devices from Avails Medical, Inc.

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (11)

  • Sterile: 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