MedSource TrueSafe Comfort Safety IV Catheter 18g 1.88"

GUDID 00816703020685

TrueSafe Comfort Safety IV Catheter 18g 1.88"

MEDSOURCE INTERNATIONAL LLC

Intravenous line recessed-needle connector

• Primary Device ID: 00816703020685
• NIH Device Record Key: e7b9b999-2d62-4732-ba15-e808156f7d71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource TrueSafe Comfort Safety IV Catheter 18g 1.88"
• Version Model Number: MS-84318
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL 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: true
• 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	00816703020685 [Primary]
GS1	10816703020682 [Package]; Package: Box [50 Units]; In Commercial Distribution
GS1	20816703020689 [Package]; Package: Case [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131555

FDA Product Code

• FOZ: Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Sterilization

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

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

[00816703020685]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-24

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