IS10112

GUDID 20816336022487

IV Extension Set 112" with 10 Drop Vented Chamber

NEOCHILD, LLC

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

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