Search Results

Found 2 results

510(k) Data Aggregation

K Number

K023540

Device Name

SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09

Manufacturer

VALUMED

Date Cleared

2003-02-04

(105 days)

Product Code

MMP

Regulation Number

878.4370

Intended Use

The various sizes of Polyethylene Equipment Covers are intended to be used to cover medical equipment in order to maintain the sterile field and as an aid in the clean up of equipment after surgery. These covers are not intended to be used as patient drapes and do not have patient contact.

Device Description

ValuMed's Cover Alls, the Sterile Equipment Covers by Custom Medical Products(K931417), Equipment Covers by United States Surgical(K964699) and the Equipment Snap Covers by Advance Medical Designs(K850959) consist of various sizes and shapes of polvethvlene covers that are positioned on surgical equipment. The covers are used to maintain a sterile field and as an aid in the clean up of equipment after surgery.

Ask a Question

K Number

K023539

Device Name

STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW

Manufacturer

VALUMED

Date Cleared

2002-12-17

(56 days)

Product Code

LHI

Regulation Number

880.5440

Intended Use

The ValuMed decanting devices are devices intended for the aseptic dispensing of solutions from I.V. containers. Each device is used as follows: Bag Decanter: Used to dispense fluids from flexible bags Vial Decanter: Used to dispense fluids from glass vials Transfer Device: Used to dispense fluids from small vials, or to transfer fluids from container to container.

Device Description

The ValuMed decanting devices are one piece, injection molded hollow tubes with one or more spiked ends. Some models have a splash guard. They are sterile, single use, disposable devices.

Ask a Question

Page 1 of 1