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BVF22 Bacteria Filter

by Exceleron Medical, LLC

BVF22 Bacteria Filter is a Class II device made by Exceleron Medical, LLC, cleared under FDA 510(k) K851070 on 14 Jun 1985 and listed in FDA GUDID since 24 Sep 2020 (UDI-DI 00819989014904), active as of 21 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 21 Oct 2026

Documents

510(k) K851070

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00819989014904 UDI-DI Date24 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK851070 Date14 Jun 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K851070 decided 14 Jun 1985 Active
  • FDA GUDID UDI-DI 00819989014904 listed 24 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K851070
  2. Listed FDA GUDID 00819989014904

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Heat/moisture exchanger/microbial medical gas filter
Model / reference
BVF22
Primary DI / UDI-DI
00819989014904
510(k) Number
FDA product code
CAH
GMDN term
Heat/moisture exchanger/microbial medical gas filter
Device class
Class II
Regulation number
868.5260
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Heat/moisture exchanger/microbial medical gas filter.

Other devices from Exceleron Medical, LLC

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Properties

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