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HIgH-Flo™ Needle Set SUPER12612

by Repro Med Systems, Inc.

HIgH-Flo™ Needle Set SUPER12612 is a Class II device made by Repro Med Systems, Inc., cleared under FDA 510(k) K180843 on 4 Apr 2019 and listed in FDA GUDID since 16 May 2019 (UDI-DI 00659443002814), active as of 22 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 22 Oct 2026

Documents

510(k) K180843

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00659443002814 UDI-DI Date16 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180843 Date4 Apr 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180843 decided 4 Apr 2019 Active
  • FDA GUDID UDI-DI 00659443002814 listed 16 May 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180843
  2. Listed FDA GUDID 00659443002814

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
HIgH-Flo™ Needle Set
Generic name
Subcutaneous infusion/injection port needle
Model / Ref / Catalog
SUPER12612
Primary DI / UDI-DI
00659443002814
510(k) Number
FDA product code
FPA
GMDN term
Subcutaneous infusion/injection port needle
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization
Size
Needle Gauge — 26 Gauge

Related devices

Category: Subcutaneous infusion/injection port needle

Cleared under the same submission (K180843)

and 8 more cleared under K180843

Similar devices

Other devices filed under FDA product code FPA (Set, administration, intravascular).

Other devices from Repro Med Systems, Inc.

See all devices from Repro Med Systems, Inc. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (8, all answered No)