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Given Vario Pump Kit 080.0012

by Medela LLC

Ref 080.0012

Given Vario Pump Kit 080.0012 is a device classified as Class I in the EU and Class II in the US made by Medela LLC, registered in EUDAMED on 19 Aug 2026 (Basic UDI-DI 07612367obouteN8), cleared under FDA 510(k) K153663 on 18 May 2016 and listed in FDA GUDID since 14 Oct 2016 (UDI-DI 07612367024419), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153663

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07612367obouteN8 Basic UDI-DI 07612367024419UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07612367024419 UDI-DI Date14 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK153663 Date18 May 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07612367obouteN8 registered 19 Aug 2026 Active
  • FDA 510(k) K153663 decided 18 May 2016 Active
  • FDA GUDID UDI-DI 07612367024419 listed 14 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K153663
  2. Listed FDA GUDID 07612367024419
  3. Registered EUDAMED 07612367obouteN8

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Given Vario Pump Kit
Generic name
Surgical suction pump
Device name
Vario Kits Accessories
Model / reference
080.0012
Primary DI / UDI-DI
07612367024419
Basic UDI-DI
07612367obouteN8
510(k) Number
FDA product code
BTA, HDB, MUU
EMDN code
A060102, A060399, A070599
GMDN term
Surgical suction pump
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4780, 884.4340, 878.5040
System or procedure pack
Procedure pack
EU registration type
System or procedure pack
Medical purpose
The Vario system/procedure packs are intended for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (including vomit) or infectious materials from a patient’s airway or respiratory support system, either during surgery or at the patient’s bedside.
GUDID distribution status
In Commercial Distribution

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: Surgical suction pump

Cleared under the same submission (K153663)

and 8 more cleared under K153663

Similar devices in this category

Other devices filed under SURGICAL DRAINAGE CONNECTION MEDICAL TUBES.

Other devices from Medela LLC

See all devices from Medela LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)