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PulseFlow DF™ PB01 Left B

by Pulse Flow Technologies

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 Number00852597007029 UDI-DI Date24 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  • Withdrawn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
PulseFlow DF™
Generic Name
Intermittent venous compression system
Model / Reference
PB01 Left B
Primary DI / UDI-DI
00852597007029
510(k) Number
FDA Product Code
JOW
GMDN Term
Intermittent venous compression system
Device Class
Class II
Regulation Number
870.5800
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K150806)

Show all (9)

Properties

  • Prescription Use
  • Serial Number
  • Expiration Date

Other properties (11)

  • 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
  • Manufacturing Date: No