Tube,feeding,CH10,L40-60cm,ENFit,black

GENERAL DESCRIPTION:
Tube,feeding,CH10,L40-60cm,ENFit,black

DEFINITION:
These nasogastric tubes with ENFit connectors are intended for enteral feeding and/or gastric decompression in patients who are unable to ingest food orally. They are suitable for use in hospitals, clinics, and other healthcare settings to deliver nutrition, medications, or fluids directly into the stomach or to remove gastric contents. The choice between CH08 and CH10 sizes depends on the specific patient's needs and clinical requirements, with CH08 typically used for infants or small children and CH10 for older children or adults. The ENFit connectors ensure compatibility with enteral feeding systems, promoting safety and reducing the risk of misconnections

TECHNICAL SPECIFICATIONS
Nasogastric Tube (NG Tube)
Available in size: CH10 (French scale) - with black color coding
Length: 40-60 cm, adjustable or pre-cut as per standard pediatric lengths. Indicate actual length.
Material: Medical-grade silicone or polyurethane for flexibility and biocompatibility
Sterility: Sterile, for single-use only
Connector Type: ENFit connector compliant with ISO 80369-3 standard
Radiopaque Marker: Present at the distal end for X-ray visualization
Initial Sterilization Method: Ethylene Oxide gas or Gamma Radiation
Free of Di(2-ethylhexyl) phthalate (DEHP)
Shelf-life: 5 Years

Primary packaging:
Unit of use: One (1) Tube, feeding, ENFit, in an individual sterilized labeled pack

Secondary packaging:
One (1) labeled box containing xxx units for the Tube, feeding, CH10, L40-60cm, ENFit, black.

QUALITY MANAGEMENT SYSTEM
Manufacturer is certified for ISO 13485 Medical devices / ISO 9001 - Quality management systems - Requirements for regulatory purposes.
Supplier is certified for ISO 9001 Quality management systems – Requirements.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDR 2017/745 as Class IIa device or higher.

SAFETY AND PRODUCT STANDARDS:
ISO 80369-3 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
ISO 20695 Enteral feeding systems — Design and testing
ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.

ENVIRONMENTAL CONDITIONS
Storage conditions: 0 - 50°C / 85% RH.
Operating conditions: 10 - 40°C / 85% RH.

WEIGHT AND VOLUME (Packaged)
Weight: gr.
Volume: dm³.

NOMENCLATURE
GMDN Code:

COMPONENT OF A KIT: Yes, S9901050 IEHK 2024,Suppl. Renewable UNIT