Skip to content

BD PhaSeal Optima 515629

by BD Switzerland Sàrl

Ref 515629

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number038290KBLRCVXF9E Basic UDI-DI 00382905156298UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00382905156298 UDI-DI Date9 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
Phaseal EUDAMED
BD PhaSeal Optima GUDID
Generic Name
Luer/non-ISO80369-standardized linear connector, single-use
Device Name
BD PhaSeal™ Optima Connecting Set
Model / Ref / Catalog
515629
Primary DI / UDI-DI
00382905156298
Basic UDI-DI
038290KBLRCVXF9E
510(k) Number
FDA Product Code
ONB
EMDN Code
A0704 Systems for reconstitution and administration of pharmaceuticals
GMDN Term
Luer/non-ISO80369-standardized linear connector, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
880.5440
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K250059)

Other devices from BD Switzerland Sàrl

See all devices from BD Switzerland Sàrl →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Administering Medicine
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No