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Bvf 2820

by Vitalograph Ireland, Ltd. 28 variants

Bvf 2820 is a Class II device made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K942779 on 13 Jul 1994 and listed in FDA GUDID since 12 May 2018 (UDI-DI 15099169284354), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K942779

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number15099169284354 UDI-DI Date12 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK942779 Date13 Jul 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K942779 decided 13 Jul 1994 Active
  • FDA GUDID UDI-DI 15099169284354 listed 12 May 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K942779
  2. Listed FDA GUDID 15099169284354

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bvf
Generic name
Breathing mouthpiece, single-use
Model / reference
2820
Primary DI / UDI-DI
15099169284354, 15099169285542
510(k) Number
FDA product code
BZG
GMDN term
Breathing mouthpiece, single-use
Device class
Class II
Regulation number
868.1840
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Breathing mouthpiece, single-use.

Other devices from Vitalograph Ireland, Ltd.

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    Class II
  • Bvf 2820

    Class II
  • Pft 2820

    Class II
  • Pfm 4300

    Class II

See all devices from Vitalograph Ireland, Ltd. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)