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Guardian 65651-395

by Cardinal Health 200, LLC

Ref 65651-395Model Medivac Guardian Canister plus

Guardian 65651-395 is a suction system canister liner (EU MDR Class I; FDA Class II; FDA product code GCX, Apparatus, Suction, Operating-Room, Wall Vacuum Powered) made by Cardinal Health 200, LLC, registered in EUDAMED on 15 Oct 2026 (Basic UDI-DI 063014000000000000004406L) and listed in FDA GUDID since 16 Jun 2016 (UDI-DI 50630140152625), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063014000000000000004406L Basic UDI-DI 50630140152625UDI-DIDate15 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number50630140152625 UDI-DI Date16 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 063014000000000000004406L registered 15 Oct 2026 Active
  • FDA GUDID UDI-DI 50630140152625 listed 16 Jun 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 50630140152625
  2. Registered EUDAMED 063014000000000000004406L

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Guardian
Generic name
Suction system canister liner
Device name
Medivac Guardian Canister plus
Model / Ref / Catalog
65651-395, Medivac Guardian Canister plus
Primary DI / UDI-DI
50630140152625
Basic UDI-DI
063014000000000000004406L
Unit of use DI
00630140152620
FDA product code
GCX
EMDN code
A06030401 Intraoperative suction containers
GMDN term
Suction system canister liner
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.6740
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1200 Milliliter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Suction system canister liner

Similar devices in this category

Other devices filed under INTRAOPERATIVE SUCTION CONTAINERS.

Other devices from Cardinal Health 200, LLC

See all devices from Cardinal Health 200, LLC →

Properties

  • Single use
  • Over-the-counter
  • Convenience kit
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)