IS10112

GUDID 20816336022487

IV Extension Set 112" with 10 Drop Vented Chamber

NEOCHILD, LLC

Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 20816336022487
• NIH Device Record Key: 5ebcb988-1f15-411a-a0c0-aed2acd093b7
• Commercial Distribution Discontinuation: 2033-07-11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IS10112
• Version Model Number: IS10112
• 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	10816336022480 [Primary]
GS1	20816336022487 [Package]; Contains: 10816336022480; Package: [50 Units]; Discontinued: 2033-07-11; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003854

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

[20816336022487]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-19
• Device Publish Date: 2023-07-11

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