Profile: Sarstedt AG & Co. manufactures & distributes equipment and consumables in the field of medicine & research. The S-Monovette® for PFA 100 contains a buffered citrate preparation that is required for use on the Dade PFA 100, particularly for patients under ASS therapy. This S-Monovette® must not be centrifuged and features a light blue screw cap to distinguish it from citrate tubes used for coagulation analysis. The S-Monovette® HCY-C is specially designed for homocysteine determination and ensures sample stability for 6 hours. The S-Monovette® is a closed blood collection system that allows the user to collect blood according to the individual patient or the condition of the veins using either the aspiration or the vacuum principle. The gentle aspiration technique has clear advantages, especially in view of the difficult vein conditions often encountered in paediatrics, geriatrics or oncology.

The company was founded in 1961, has revenues of USD 25-50 Million, has ~200 employees and is ISO 9001, CE certified.

FDA Registration Number: 2242368

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• Automated Sedimentation Rate Device (FDA Code: GKB / 864.5800) An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease.

• Benchtop Centrifuges

• Black Stopper Blood Collection Tube

• Blender/Mixer (FDA Code: JRO / 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.

• Blood and Plasma Warming Device (FDA Code: KZL / 864.9205) A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.

• Blood Banking, Platelet Incubators

• Blood Collect Tubes

• 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.

• Blood Collection Tube

• Blood Collection Tube Holder

• Blood Donor Chair (FDA Code: FML / 880.6140) A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.

• Blood Lancet Needle (Blade Type)

• Blood Lancet Needle (Pen Type)

• Blood Lancets

• Blood Mixing and Weighing Device (FDA Code: KSQ / 864.9195) A blood mixing device is a device intended for medical purposes that is used to mix blood or blood components by agitation. A blood weighing device is a device intended for medical purposes that is used to weigh blood or blood components as they are collected.

• Blood Tube Mixer (FDA Code: GLE / 862.2050)

• Blue Stopper Blood Collection Tube

• Brown Stopper Blood Collection Tube

• Capillary Blood Collection Tubes (FDA Code: GIO / 864.6150) A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

• Carts

• Centrifugal Chemistry Analyzer (FDA Code: JJG / 862.2140) A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

• Centrifuge Aids

• Centrifuges

• Co2 Water Jacketed Incubators

• Diagnostic Aids

• Disposable Blood Lancet Needles

• Disposable Nonelectric Urine Flow Rate Measuring Device (FDA Code: FFG / 876.1800) A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.

• Erythrocyte Sedimentation Rate Test (FDA Code: JPH / 864.6700) An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An increased rate indicates tissue damage or inflammation.

• General Diagnostic Supplies

• General Examination Supplies

• General Medical Supplies

• General Purpose Reagent (FDA Code: LDT)

• Giant Test Tubes

• Graduated Liquid Medication Container (FDA Code: KYW / 880.6430) A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.

• Green Stopper Blood Collection Tube

• Grey Stopper Blood Collection Tube

• 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.

• Hospital pull Carts

• Hospital Push Carts

• Incubators

• Incubators and Shakers, Multi-Tier Shakers

• Incubators and Shakers, Rocking Shakers

• Incubators and Shakers, Rotating Tube Shakers

• 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.

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

• Laboratory Centrifuges, Floor

• Laboratory cooled incubators

• Lavender Blood Collection Tube

• Manual Platelet Counter (FDA Code: GLG / 864.6160) A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.