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VentiSure2 301-5803

by Engineered Medical Systems, LLC

VentiSure2 301-5803 is a Class II device made by Engineered Medical Systems, LLC, listed in FDA GUDID since 30 Sep 2016 (UDI-DI 00841470105372), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841470105372 UDI-DI Date30 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  • Withdrawn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
VentiSure2
Generic name
Pulmonary resuscitator, manual, single-use
Model / reference
301-5803
Primary DI / UDI-DI
00841470105372
FDA product code
BTM
GMDN term
Pulmonary resuscitator, manual, single-use
Device class
Class II
Regulation number
868.5915
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary resuscitator, manual, single-use

Similar devices in this category

Other devices filed under Pulmonary resuscitator, manual, single-use.

Other devices from Engineered Medical Systems, LLC

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Properties

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