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Flushing Medium 10845060D

by Origio A/S

Flushing Medium 10845060D is an IVF medium (FDA Class II; FDA product code MQL, Media, Reproductive) made by Origio A/S, cleared under FDA 510(k) K991327 on 4 May 2000 and listed in FDA GUDID since 24 Jun 2016 (UDI-DI 20888937817519), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K991327

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20888937817519 UDI-DI Date24 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK991327 Date4 May 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K991327 decided 4 May 2000 Active
  • FDA GUDID UDI-DI 20888937817519 listed 24 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K991327
  2. Listed FDA GUDID 20888937817519

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Flushing Medium
Generic name
IVF medium
Model / reference
10845060D
Primary DI / UDI-DI
20888937817519
510(k) Number
FDA product code
MQL
GMDN term
IVF medium
Device class
Class II
Regulation number
884.6180
GUDID distribution status
In Commercial Distribution

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Other devices filed under IVF medium.

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Properties

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