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XinjingProWellness™ 1011-B

by Tianjin Newtrans Technology Development

XinjingProWellness™ 1011-B is a Class I device made by Tianjin Newtrans Technology Development, listed in FDA GUDID since 24 Dec 2021 (UDI-DI 16973881680061), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number16973881680061 UDI-DI Date24 Dec 2021ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
XinjingProWellness™
Generic name
Airway device cleaning utensil, noninvasive, reusable
Model / reference
1011-B
Primary DI / UDI-DI
16973881680061
FDA product code
EPE
GMDN term
Airway device cleaning utensil, noninvasive, reusable
Device class
Class I
Regulation number
868.5795
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code EPE (Brush, Cleaning, Tracheal Tube).

Other devices from Tianjin Newtrans Technology Development

  • 1008-C

    Class I
  • 1009-C

    Class II
  • 1010-C

    Class II
  • 2004-E

    Class I

See all devices from Tianjin Newtrans Technology Development →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)