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CAPIOX® Holders 801139

by Terumo Cardiovascular Systems Corporation

CAPIOX Holders 801139 is a portable active medical device mount (FDA Class I; FDA product code KRI, Accessory Equipment, Cardiopulmonary Bypass) made by Terumo Cardiovascular Systems Corporation, listed in FDA GUDID since 29 Jul 2022 (UDI-DI 00886799000571), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00886799000571 UDI-DI Date29 Jul 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
CAPIOX® Holders
Generic name
Portable active medical device mount
Model / Ref / Catalog
801139
Primary DI / UDI-DI
00886799000571
FDA product code
KRI
GMDN term
Portable active medical device mount
Device class
Class I
Regulation number
870.4200
GUDID distribution status
In Commercial Distribution

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Properties

  • Prescription use
  • Premarket exempt
  • Manufacturing date
Other properties (12, all answered No)