Bottle-to-Bottle

• • Ongoing Z-2643-2024 FDA Class II ·initiated 3 Jun 2024

  During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

510(k) Number

K811268 ↗

FDA Product Code

KPE

Device Class

Class II

Regulation

21 CFR Part 880.5025

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 10CC Control Syringe

  Class II

  FDA 510(k) K873588 Active Cleared 23 Oct 1987

• Arterial-Venous Compression Dressing

  Not classified

  FDA 510(k) K851489 Active Cleared 11 Jun 1985

• I.V. Bottle (Ridgid) Open recall

  Class II

  FDA 510(k) K811234 Active Cleared 18 Jun 1981

• Glass Vials Open recall

  Class II

  FDA 510(k) K811269 Active Cleared 16 Jun 1981

• Fluoroscope Band Bag

  Class II

  FDA 510(k) K861785 Active Cleared 13 Jun 1986

• Operating Room Tray Set

  Class I

  FDA 510(k) K840021 Active Cleared 15 Mar 1984

See all devices from Medi-Plast Intl., Inc. →

• What is the Bottle-to-Bottle device used for?

  The Bottle-to-Bottle is a container device specifically designed for intravenous (IV) applications to facilitate the transfer of fluids between bottles in medical settings, particularly general hospital environments.

• How is the Bottle-to-Bottle device supplied?

  The Bottle-to-Bottle device is supplied by Medi-Plast Intl., Inc. It is classified as a Class II medical device and received FDA 510(k) clearance on June 18, 1981, with the product code KPE.

• Is the Bottle-to-Bottle device single-use or reusable?

  The device data does not specify whether the Bottle-to-Bottle is designed for single-use or multiple uses. For proper usage instructions, users should consult the manufacturer's guidelines or product documentation.

• What regulatory approvals does the Bottle-to-Bottle device have?

  The Bottle-to-Bottle device has received FDA 510(k) clearance, which means it has been determined to be substantially equivalent to other legally marketed devices. It is classified as a Class II medical device with product code KPE.