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EasySpeak RM21353

by Intersurgical Incorporated

EasySpeak RM21353 is a Class I device made by Intersurgical Incorporated, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00619498213535), 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 Number00619498213535 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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
EasySpeak
Generic name
Breathing mouthpiece, single-use
Model / reference
RM21353
Primary DI / UDI-DI
00619498213535
FDA product code
BYP
GMDN term
Breathing mouthpiece, single-use
Device class
Class I
Regulation number
868.5620
GUDID distribution status
In Commercial Distribution
Size
Length — 17 Centimeter

Related devices

Category: Breathing mouthpiece, single-use

Similar devices in this category

Other devices filed under Breathing mouthpiece, single-use.

Other devices from Intersurgical Incorporated

See all devices from Intersurgical Incorporated →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)