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Medline Bcllad

by Medline Industries, Inc.

Medline Bcllad is a Class II device made by Medline Industries, Inc., cleared under FDA 510(k) K200027 on 9 Sep 2020 and listed in FDA GUDID since 5 Mar 2024 (UDI-DI 10193489189650), 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) K200027

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 Number10193489189650 UDI-DI Date5 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK200027 Date9 Sep 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K200027 decided 9 Sep 2020 Active
  • FDA GUDID UDI-DI 10193489189650 listed 5 Mar 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K200027
  2. Listed FDA GUDID 10193489189650

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Medline
Generic name
Blood collection set, invasive
Model / Ref / Catalog
BCLLAD
Primary DI / UDI-DI
10193489189650
510(k) Number
FDA product code
JKA
GMDN term
Blood collection set, invasive
Device class
Class II
Regulation number
862.1675
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)