Profile: Able Global Healthcare Sdn. Bhd. is a provider of medical diagnostic products. We offer products in many medicals sectors that include radiology, diagnostic, cardiology, surgeons products, ICU/CCU products and laboratory products. Our cardiology division renders ECG machines, blood pressure monitors, cardiac event recorders, defibrillators, spirometers and digital ECG holter systems. Our Pointe 180 II chemical analyzer is a second generation analyzer. Improvements include a larger analyzer screen and printer, optional computer keyboard, removable flow cell, built-in vacuum pump and external waste bottle, larger internal memory, 43 stored assays, patient data storage and report printer as well as Levey-Jennings control plots. Our automatic inflation is a unique upright design, detects irregular heart beat, four memory zones, different color lights for various blood pressure readings, and easy fit cuff.

The company was founded in 1993, has revenues of USD 5-10 Million, has ~20 employees and is ISO 9000, ISO 9001, CE certified.

FDA Registration Number: 1057199

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• Integrated Anesthesia Machines

• Interventional Cardiology Surgical Drapes

• Intravenous Administration Kit (FDA Code: FPA / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

• Laboratory Coat

• Lightweight Body Bag Envelope Zipper Style

• Lightweight Surgical Gowns

• Linen

• Manual Stethoscope (FDA Code: LDE / 870.1875) A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

• Neurosurgery Surgical Drapes

• New Or Used Disposable Examination Gowns and Capes

• Non-Mercury Thermometers

• Non-Metal Vaginal Speculum (FDA Code: HIB / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Non-reinforced Surgical Gowns

• Nonresorbable Gauze/sponge for External Use (FDA Code: NAB / 878.4014) A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

• Nylon Corpse Retrieving Body Bag

• Operating Room Equipment Table Extensions

• Operating Room Shoe Cover (FDA Code: FXP / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

• Ophthalmic Surgical Drapes

• Orthopedic Surgical Drapes

• Oxygen Masks (FDA Code: BYG / 868.5580) An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

• Patient Examination Gowns & Capes

• Patient Examination Gowns and Capes (FDA Code: FME / 880.6265) An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.

• Pediatric Urine Collector (FDA Code: KNX / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• Personnel Protective Shield (FDA Code: KPY / 892.6500) A personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation. This generic type of device may include articles of clothing, furniture, and movable or stationary structures.

• Plastic Blood Lancets

• Protective Surgical Cap

• Radiography & Fluoroscopy

• Rayon Cellulose Sponge

• Reusable Surgical Gowns

• Rubber Body Bag For Air Transport

• Rubber Elastic Bandages

• Scalpel Blade (FDA Code: GES / 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.

• Self Adhesive Elastic Bandage

• Single Handed Scalpel Blade Remover

• Spiral CT San

• Stainless Steel Blood Lancets

• Sterile Surgical Drapes (FDA Code: KKX / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• Sterilization Wrap (FDA Code: FRG / 880.6850) A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

• Suction Catheter

• Surgery Prep Kit

• Surgical Caps

• Surgical Caps (FDA Code: FYF / 878.4040)

• Surgical Drapes (FDA Code: KKX / 878.4370)

• Surgical Drapes & Packs (FDA Code: KKX / 878.4370)

• Surgical Gowns

• Surgical Gowns (FDA Code: FYA / 878.4040)

• Surgical Isolation Gown (FDA Code: FYC / 878.4040)

• Surgical Mask for Nurses

• Surgical Masks (FDA Code: FXX / 878.4040)

• Tie-On Surgical Masks