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Swan-Ganz True Size 096F6

by Edwards Lifesciences LLC 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00690103218602 UDI-DI Date16 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Swan-Ganz True Size
Generic Name
Pulmonary artery balloon catheter, electrical
Model / Ref / Catalog
096F6, 096F6P
Primary DI / UDI-DI
00690103218602
FDA Product Code
DQO, DYG, DQE, KRA
GMDN Term
Pulmonary artery balloon catheter, electrical
Device Class
Class II
Regulation Number
870.1200, 870.1240, 870.1230, 870.1210
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Edwards Lifesciences LLC

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Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Implantable: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No