ITL Asia Pacific Sdn. Bhd.

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Contact: Emily Rossiter
Web: http://www.itl-limited.com
E-Mail:
Address: 2-14 Persiaran Perindustrian, 29A, Pengkalan, Ipoh 31500, Malaysia
Phone: +60-(5)-321-7586 | Fax: +60-(5)-321-7498 | Map/Directions >>

Profile: ITL Asia Pacific Sdn. Bhd. designs and manufactures procedure packs. Our CrocClamp™ is a non-reopening single use tubing clamp suitable for use on medical tubing during blood collection. It provides permanent blocking for the flexible tube. Our DonorCare® needle guard is an aid to reduce the needle stick injury to the health care workers, donors, cleaning staff and contaminated waste disposal staff. Our standardized procedure packs include general packs, arthroscopy packs, basic set-up packs and ophthalmic packs.

FDA Registration Number: 3003895930
US Agent: Susan Finneran / Regulatory Compliance Experts, Inc.
Phone: +1-(781)-664-0074 E-Mail:

7 Products/Services (Click for related suppliers)

• Blood Bank Supplies (FDA Code: KSS / 864.9050)

Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.

• Blood Collection Lancet (FDA Code: FMK / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Blood Collection Systems (FDA Code: JKA / 862.1675)

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

• Heat-Sealing Device (FDA Code: KSD / 864.9750)

A heat-sealing device is a device intended for medical purposes that uses heat to seal plastic bags containing blood or blood components.

• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050)

General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Microbiology Diagnostic Device (FDA Code: LIB / 866.2660)

A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570)

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.