NC30800T

GUDID 10816336021018

8.0 Fr. Silicone Urinary Collection Kit with catheter

NEOCHILD, LLC

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• Primary Device ID: 10816336021018
• NIH Device Record Key: 05ec82dd-d957-41dc-8ac5-50dd743a2eb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC30800T
• Version Model Number: NC30800T
• Company DUNS: 022760922
• Company Name: NEOCHILD, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10816336020387 [Primary]
GS1	10816336021018 [Package]; Contains: 10816336020387; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• LRO: General Surgery Tray

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-09
• Device Publish Date: 2018-02-19

Devices Manufactured by NEOCHILD, LLC

• 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
• 10816336020967 - NC401500: 2023-12-04 22 gauge, 1.5 inch Spinal Needle
• 10816336020974 - NC50000T: 2023-12-04 PICC Insertion Tray - No Catheter