TrueCare Biomedix TCBINF6480 - 102", ONE CLAVE 6" FROM MALE LL, 0.2 MICRON FILTER 14" FROM MALE LL, SLIDE CLAMP, BAXTER FLOGARD COMPATIBLE IV ADMIN SET, 50/BX
Universal vented/non-vented 10 drop/ml spike, non-DEHP, PVC fluid path, 102 length, one Clave Y-Site, 0.2 micron GVS Speedflow in-line filter, roller clamp, slide clamp, pyrogen and latex-free
Our IV Administration sets are individually blister-packaged in quantiles of 50 per box and features patient information directly on the exterior of the package.
Features
- Universal vented/non-vented 10 drop/ml spike.
- Non-DEHP.
- PVC fluid path.
- 102" length.
- One Clave Y-Site.
- 0.2 micron GVS Speedflow in-line filter.
- Roller clamp.
- Slide clamp.
- Pyrogen and latex-free.
Cross-Reference
- Baxter 2H8480
Device Characteristics
- What MRI safety information does the labeling contain? Labeling does not contain MRI Safety Information.
- Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No.
- Device labeled as "Not made with natural rubber latex": No.
- For Single-Use: Yes.
- Prescription Use (Rx): No.
- Over the Counter (OTC): No.
- Kit: No
- Combination Product: No.
- Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): No.
Sterilization
- Device Packaged as Sterile: Yes.
- Requires Sterilization Prior to Use: No.
Slide clamp
Slide clamp used to regulate the flow of IV solution. The slide clamp has a graduated opening through which the IV tubing passes. Pushing the tube into the narrow end of the opening constricts it and reduces the flowrate of the IV solution. Sliding the wide end of the opening over the tube increases the flow rate.
Roller clamp
Roller clamp equipped with a small roller that may be rolled counterclockwise to close off primary IV tubing or clockwise to open it. The roller clamp may also be manipulated to increase and decrease the flow of the IVsolution and is easily moved with the thumb, thus making it a one-handed convenience in the administration of IV therapy.
Why vented/non-vented Spike?
A vented/non-vented or "universal" spike allows an administration set to be used with all types of solution containers. The vent should be open when infusing from non-collapsible containers (glass and semi-rigid plastic) and closed when infusing from collapsible plastic containers (bags).
0.2 Micron Filter
The 0.2-micron filter was specifically designed for sterilization and bacteria retentive applications.
0.2 micron filter is capable of retaining 1 X 107colony forming units of Brevundimonas diminuta per square centimeter of filter, bacteria commonly of a 0.3 micron size.The 0.2 micron filter retains most bacteria, fungus, and particulate matter, but no viruses. 0.2 micron filters is standard in pharmaceutical manufacturing because of its greater (double that of a single 0.2 micron) sterilizing and particle removing capacity.
Why PVC?
Polyvinyl chloride (PVC) plastic is used to manufacture a huge number of articles for daily life, e.g. toys, building material such as flooring, cables, as well as medical products. PVC is the most widely used thermoplastic material in medical devices due to its:
Safety
Before medical devices can be used all the components must be fully understood from a toxicological point of view. Consequently all the materials used to make such components have to be thoroughly tested and assessed in the EU before being accepted. Experience based on all available knowledge from international environmental and healthcare authorities shows that PVC is safe. It is the best material existing today which optimises all performance and safety requirements at lowest cost.
Chemical stability
Material used in medical applications must be capable of accepting or conveying a variety of liquids without themselves undergoing any significant changes in composition or properties.
Biocompatibility
Whenever plastics are used in direct contact with the patients tissue or blood, a high degree of compatibility is essential between the tissue/blood and the material. The significance of this property increases with time over which plastic is in contact with the tissue or blood. PVC is characterised by high biocompatibility, and this can be increased further by appropriate surface modification.
Clarity and transparency
Because of its physical properties, products made from PVC can be formulated with excellent transparency to allow for continual monitoring of fluid flow. If colour-coded application is needed, virtually any colour can be created.
Flexibility, durability and dependability
Not only does PVC offer the flexibility necessary for applications such as blood bags and IV containers, but can also be relied upon for its strength and durability, even under changing temperatures and conditions.
Sterilizability
The absence of sources of infection is a fundamental requirement in medical product applications. PVC products can be easily sterilized using such methods as steam, radiation or ethylene oxide.
Compatibility
PVC is compatible with virtually all pharmaceutical products in healthcare facilities today. It also has excellent water and chemical resistance, helping to keep solutions sterile.
Resistance to chemical stress cracking
PVC's resilience helps assure that medical products function consistently, for extended use, in demanding applications. Ease of processing PVC can easily be extruded to make IV tubing, thermoformed to make 'blister' packaging or blow moulding to make hollow rigid containers. This versatility is a major reason why PVC is the material of choice for medical product and packaging designers.
PVC in medical products
The use of PVC in medical devices represents a very minor percentage of the total amounts of PVC manufactured each year. Nonetheless the use of plasticized PVC in a wide range of medical devices has been very important for a number of reasons.
- Flexibility in a variety of physical forms from tubes to membranes.
- Chemical stability and possibility to sterilise.
- Low cost and wide availability.
- Lack of evidence of significant adverse consequences in patients.
Pyrogen-free
Pyrogen is any substance that causes a fever. The most commonly thought of pyrogens are bacterial endotoxins and exotoxins, although the host body (human or animal) can also produce pyrogens. The most commonly assayed for pyrogen is lipopolysaccharide, or LPS. It is a component of the bacterial wall of Gram-negative bacteria and is released upon breakdown of the cell wall or bacterial cell lysis.
Pyrogen-free products are manufactured in settings that prevent the deposition of bacteria and other agents on the products.
DEHP Free
Our IV sets are DEHP free. Infusion Therapy Standards of Practice advise to usee administration sets free of di-ethylhexyl-phthalate (DEHP) to administer lipid-based infusates, such as IVFE or TNA. DEHP is lipophilic and is extracted into the lipid solution with commonly used polyvinyl chloride administration sets and containers. DEHP is considered a toxin, and studies have demonstrated increased DEHP levels in lipid solutions, which is especially a risk with neonatal, pediatric, and long-term home care patients (42).
