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PFT KIT F, VBMax 35e Filter Kit PFT KIT F, VBMax 35e - 189175

by A-M Systems, LLC

Listed FDA GUDID listing, no authorization on record

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 Number00817081028683 UDI-DI Date17 Jul 2026ListedStatusListed GUDID: 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  • Withdrawn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
PFT KIT F, VBMax 35e Filter Kit
Generic Name
Pulmonary function testing kit
Model / Ref / Catalog
PFT KIT F, VBMax 35e - 189175, 189175
Primary DI / UDI-DI
00817081028683
510(k) Number
FDA Product Code
CAH
GMDN Term
Pulmonary function testing kit
Device Class
Class II
Regulation Number
868.5260
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K000654)

Show all (12)

Other devices from A-M Systems, Inc.

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No