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Angle piece Orange DCS 077.0101

by Medela LLC

Ref 077.0101

Angle piece Orange DCS 077.0101 is a device classified as Class I in the EU and Class II in the US made by Medela LLC, registered in EUDAMED on 30 Jun 2026 (Basic UDI-DI 07612367rvbnaeQL), cleared under FDA 510(k) K170329 on 24 Mar 2017 (3 earlier submissions) and listed in FDA GUDID since 7 Jun 2023 (UDI-DI 07612367015349), active as of 25 Oct 2026. One FDA recall is linked to it.

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 ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170329

+3 more

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07612367rvbnaeQL Basic UDI-DI 07612367015349UDI-DIDate30 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07612367015349 UDI-DI Date7 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170329 Date24 Mar 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07612367rvbnaeQL registered 30 Jun 2026 Active
  • FDA 510(k) K170329 decided 24 Mar 2017 Active· +3 more in the status table
  • FDA GUDID UDI-DI 07612367015349 listed 7 Jun 2023 Listed

Recalls

1 recall · FDA

    • Terminated Z-1502-2021 FDA Class II initiated 2 Dec 2020

    Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24".

Timeline

7 dated events

  1. Cleared FDA 510(k) K130123
  2. Cleared FDA 510(k) K150134
  3. Cleared FDA 510(k) K153663
  4. Cleared FDA 510(k) K170329
  5. Recall initiated FDA recalls Z-1502-2021
  6. Listed FDA GUDID 07612367015349
  7. Registered EUDAMED 07612367rvbnaeQL

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  • Withdrawn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
Angle piece Orange DCS
Generic name
Surgical suction system collection container, single-use
Model / reference
077.0101
Primary DI / UDI-DI
07612367015349
Basic UDI-DI
07612367rvbnaeQL
510(k) Number
FDA product code
BTA, QPB, MUU, HDB
EMDN code
A070199 Adapters and connectors - other
GMDN term
Surgical suction system collection container, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
878.4780, 878.5040, 884.4340
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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 system collection container, single-use

Cleared under the same submission (K130123)

and 8 more cleared under K130123

Cleared under the same submission (K150134)

and 8 more cleared under K150134

Similar devices in this category

Other devices filed under ADAPTERS AND CONNECTORS - OTHER.

Other devices from Medela LLC

See all devices from Medela LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)