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Jaeger V-577400-13

by Jaeger Medical GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04250892908984 UDI-DI Date24 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1730-2024 FDA Class I initiated 8 Apr 2024

    Potential of the nozzle separating during patient use.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Jaeger
Generic Name
Pulmonary function analysis system, adult
Model / Ref / Catalog
V-577400-13
Primary DI / UDI-DI
04250892908984
510(k) Number
FDA Product Code
BZC
GMDN Term
Pulmonary function analysis system, adult
Device Class
Class II
Regulation Number
868.1880
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K150810)

Show all (12)

Other devices from Jaeger Medical GmbH

See all devices from Jaeger Medical GmbH →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No