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SpiroFlow E5020

by Spirometrics, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00855784004047 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SpiroFlow
Generic Name
Peak flow meter, manual
Model / Ref / Catalog
E5020, E5020-2
Primary DI / UDI-DI
00855784004047
510(k) Number
FDA Product Code
BZH
GMDN Term
Peak flow meter, manual
Device Class
Class II
Regulation Number
868.1860
GUDID distribution status
Not in Commercial Distribution

Other devices from Spirometrics, Inc.

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Properties

  • Contains Latex
  • Over-the-Counter
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No