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Infant Flow 777000XL

by Vyaire Medical, Inc.

Infant Flow 777000XL is a Class II device made by Vyaire Medical, Inc., cleared under FDA 510(k) K031745 on 13 Feb 2004 and listed in FDA GUDID since 5 Mar 2021 (UDI-DI 10190752151925), 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) K031745

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 Number10190752151925 UDI-DI Date5 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK031745 Date13 Feb 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031745 decided 13 Feb 2004 Active
  • FDA GUDID UDI-DI 10190752151925 listed 5 Mar 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K031745
  2. Listed FDA GUDID 10190752151925

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Infant Flow
Generic name
Nasal oxygen cannula, CPAP
Model / Ref / Catalog
777000XL
Primary DI / UDI-DI
10190752151925
510(k) Number
FDA product code
BZD
GMDN term
Nasal oxygen cannula, CPAP
Device class
Class II
Regulation number
868.5905
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nasal oxygen cannula, CPAP

Cleared under the same submission (K031745)

and 8 more cleared under K031745

Similar devices in this category

Other devices filed under Nasal oxygen cannula, CPAP.

Other devices from Vyaire Medical, Inc.

  • Ltv 14982-001

    Class II

  • Vmax 29122-507

    Class II

  • 3100B Hfov 11744-Hrck

    Class III

  • Infant Flow™ 777000M

    Class II

See all devices from Vyaire Medical, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)