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Vyaire 2009110-003

by Airlife, Inc.

Vyaire 2009110-003 is a Class II device made by Airlife, Inc., cleared under FDA 510(k) K020003 on 7 Nov 2002 and listed in FDA GUDID since 15 Nov 2018 (UDI-DI 08809083941482), 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) K020003

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 Number08809083941482 UDI-DI Date15 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020003 Date7 Nov 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020003 decided 7 Nov 2002 Active
  • FDA GUDID UDI-DI 08809083941482 listed 15 Nov 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020003
  2. Listed FDA GUDID 08809083941482

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vyaire
Generic name
Electrocardiographic electrode, single-use
Model / reference
2009110-003
Primary DI / UDI-DI
08809083941482
510(k) Number
FDA product code
DRX
GMDN term
Electrocardiographic electrode, single-use
Device class
Class II
Regulation number
870.2360
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic electrode, single-use

Cleared under the same submission (K020003)

and 8 more cleared under K020003

Similar devices in this category

Other devices filed under Electrocardiographic electrode, single-use.

Other devices from Airlife, Inc.

See all devices from Airlife, Inc. →

Properties

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