IS60ENOC

GUDID 02081633602005

Enteral Only Tubing 60" with Step Connector Cap

NEOCHILD, LLC

Enteral tube extension

• Primary Device ID: 02081633602005
• NIH Device Record Key: 1e60b22f-be7a-463d-8c2a-b703f2294918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IS60ENOC
• Version Model Number: IS60ENOC
• Company DUNS: 022760922
• Company Name: NEOCHILD, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	02081633602005 [Package]; Contains: 10816336020004; Package: [50 Units]; In Commercial Distribution
GS1	10816336020004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082710

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

[02081633602005]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-20
• Device Publish Date: 2024-06-12

Devices Manufactured by NEOCHILD, LLC

• 20816336020971 - KMI-UACTRAYH: 2024-07-23
• 02081633602005 - IS60ENOC: 2024-06-20Enteral Only Tubing 60" with Step Connector Cap
• 02081633602005 - IS60ENOC: 2024-06-20 Enteral Only Tubing 60" with Step Connector Cap
• 20816336022739 - NC23000T: 2024-04-01 Catheterization Tray
• 20816336022388 - NC1P65SE-ENF: 2024-01-19 Feeding Tube 6.5 Fr. x 40 cm. - Polyurethane (ISO 80369-3 Compatible)
• 20816336022203 - NC600500-ENF: 2023-12-27 Enteral Only 5mL Syringe with Oral Cap (ISO 80369-3 Compatible)
• 20816336022678 - NC603000-ENF: 2023-12-27 Enteral Only 30mL Syringe with Oral Cap (ISO 80369-3 Compatible)
• 20816336022784 - NC601000-ENF: 2023-12-27 Enteral Only 10mL Syringe with Oral Cap (ISO 8036-3 Compatible)
• 10816336020950 - NC401000: 2023-12-04 22 gauge, 1.0 inch Spinal Needle