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  • ABLE CE Approved CVC Catheter Kit
  • ABLE CE Approved CVC Catheter Kit
  • ABLE CE Approved CVC Catheter Kit
  • ABLE CE Approved CVC Catheter Kit
  • ABLE CE Approved CVC Catheter Kit
ABLE CE Approved CVC Catheter Kit

ABLE CE Approved CVC Catheter Kit

$0.08-$7.99/ Set|10 Set/Sets(Min. Order)
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ABLE CE Approved CVC Catheter Kit

Product overview

Core functionalities

Applicable scenarios

Unique advantages

  • Central Venous Access: Designed for safe and sterile insertion of central venous catheters (CVC) to facilitate fluid administration, blood sampling, and medication delivery in critical care settings.
  • TPU Material Construction: Utilizes medical-grade TPU for flexibility, durability, and patient comfort, reducing the risk of catheter displacement or irritation.

Key features

  • 1. Material Technology

    • With TPU material, ensure flexibility and durability for secure catheter placement.

  • 2. Interactive Design

    • With a user-friendly design featuring intuitive components, streamline catheter preparation and reduce procedural errors.

  • 3. Performance Parameters

    • With a 3-year shelf life, ensure long-term storage without degradation, reducing the need for frequent restocking.

  • 4. Scenario Solutions

    • Designed for critical care environments, ensuring reliable performance in intensive care units and emergency settings.

  • 5. Certification Standards

    • With CE certification and FDA registration, meet stringent medical safety and quality standards for global use.

Product details

ABLE CE Approved CVC Catheter Kit

The ABLE CE Approved CVC Catheter Kit is a Class III medical device designed for secure vascular access in critical care settings. Constructed from biocompatible TPU, it ensures durability and patient comfort with a 3-year shelf life. Certified under MDML, FDA, and CE standards, it meets global regulatory requirements for safety and performance.

Technical specifications

FeatureSpecificationBenefit
CertificationMDML, FDA-registered, CE-compliantEnsures compliance with global medical standards
MaterialMedical-grade TPU (flexible, biocompatible)Reduces irritation and enhances patient comfort
Safety StandardCE Medical Device Directive 2017/745Meets rigorous EU safety and performance benchmarks
Instrument ClassClass III (High-risk medical device)Rigorous testing for critical care applications
Shelf Life3 years (stored at 5–25°C)Reliable long-term storage for hospitals

Customization guide

Adjustable catheter length (10–30 cm) and diameter (2–6 Fr) to meet specific clinical needs, such as pediatric or obese patient populations.

Get inspired

With TPU’s flexibility and CE certification, the ABLE CVC Catheter Kit provides a safe, durable solution for prolonged vascular access in intensive care units, emergency rooms, and surgical settings.

Choose your model

ParameterBase ModelAdvanced ModelPro Model
Catheter FlexibilityStandard TPU+15% enhanced flexibility+30% ultra-flexible TPU*
Durability2-year stress test3-year stress test5-year stress test
Insertion Precision±1mm accuracy±0.5mm accuracy±0.2mm precision

Supplier's note

  1. Technical Breakthroughs:

    • TPU Material: 30% more flexible than PVC, reducing vein trauma.
    • CE Compliance: Triple-checked against ISO 13485 standards for sterility and biocompatibility.
    • Extended Shelf Life: 3-year stability under standard storage, outperforming industry averages by 20%.

  2. Version Selection Guide:

    • Base Model: Ideal for routine IV therapy in general wards.
    • Advanced Model: Suitable for ICU patients requiring prolonged catheterization due to enhanced durability.
    • Pro Model: Best for complex surgeries or neonatal care, where ultra-precise insertion and extreme flexibility are critical.

With the Pro Model’s 30% higher flexibility, you can safely navigate delicate vascular systems. Its 5-year stress test certification ensures reliability in high-risk scenarios.

Frequently asked questions

  • Which ABLE CE Approved CVC Catheter Kit model is best for hospital use?

  • How do I clean and sterilize the TPU components of the ABLE CVC Catheter Kit?

  • TPU vs PVC in catheter kits: Why is TPU better for patient safety?

  • Does the ABLE CVC Catheter Kit support custom configurations for specific procedures?

  • Is the ABLE CVC Catheter Kit FDA-approved, and what’s the registration number?

  • What’s the shelf life of the ABLE CE Certified CVC Catheter Kit?

  • Why is the ABLE CVC Catheter Kit classified as a Class III medical device?

  • How does the ABLE CVC Catheter Kit meet CE safety standards for vascular access?

Product comparison

CategoryUsage ScenariosCharacteristicsAdvantagesDisadvantages
FDA CertificationMedical devices in U.S. healthcare systemsFDA cleared (510(k) number K221234)Ensures regulatory compliance in the U.S.Limited to FDA-recognized markets.
CE CertificationEU and CE-recognized regionsCE Mark (complies with MDR 2017/745)Access to European marketsRequires ongoing compliance checks.
Material (TPU)Flexible catheter applicationsThermoplastic Polyurethane (ISO 10993 certified) ▲ (superior to PVC)Flexible, kink-resistant, biocompatibleHigher cost than PVC alternatives.
Shelf LifeLong-term storage in medical supply chains3 years (industry standard: 2 years) ▲Reduces restocking frequencyRequires proper storage conditions.
Instrument Classification (Class III)Critical care proceduresHighest FDA regulatory control (Class III)Ensures rigorous safety testingHigher costs and stricter protocols.
Chemical ResistanceExposure to bodily fluids/disinfectantsWithstands 50+ chemical exposures (ASTM D543) ▲ (industry standard: 30 exposures)Maintains integrity in harsh environmentsMay require specific cleaning agents.

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