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BluWing MER 1921

by Mercedes Medical LLC

BluWing MER 1921 is a Class II device made by Mercedes Medical LLC, cleared under FDA 510(k) K163093 on 14 Mar 2017 and listed in FDA GUDID since 1 Jul 2017 (UDI-DI 00850011007228), 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) K163093

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 Number00850011007228 UDI-DI Date1 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK163093 Date14 Mar 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163093 decided 14 Mar 2017 Active
  • FDA GUDID UDI-DI 00850011007228 listed 1 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163093
  2. Listed FDA GUDID 00850011007228

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
BluWing
Generic name
Venous butterfly needle/set
Model / Ref / Catalog
MER 1921
Primary DI / UDI-DI
00850011007228
510(k) Number
FDA product code
FMI
GMDN term
Venous butterfly needle/set
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

Related devices

Category: Venous butterfly needle/set

Cleared under the same submission (K163093)

and 2 more cleared under K163093

Similar devices

Other devices filed under FDA product code FMI (Needle, Hypodermic, Single Lumen).

Other devices from Mercedes Medical LLC

See all devices from Mercedes Medical LLC →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)