ClearLine MD

GUDID 00863193000338

ClearLine IV, (the new product name of AirPurge System - Control Unit), is intended for detection and automatic removal of air in intravenous lines during administration of intravenous solutions, blood and blood products. It is indicated for use in the Operating Room and post anesthesia care areas. The ClearLine IV is placed distal to I.V. bags using gravity feed or pressure, and may be used with or without fluid warmer.

ANESTHESIA SAFETY PRODUCTS, LLC

Haemodialysis system air/foam detector

• Primary Device ID: 00863193000338
• NIH Device Record Key: 2426cd91-c021-45e8-a299-37d8dd98bbc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearLine MD
• Version Model Number: Part#:2126
• Company DUNS: 364188032
• Company Name: ANESTHESIA SAFETY PRODUCTS, 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00863193000338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN080009

FDA Product Code

• OKL: Intravascular Administration Set, Automated Air Removal System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [ClearLine MD]

• 00863193000338: ClearLine IV, (the new product name of AirPurge System - Control Unit), is intended for detectio
• 00863193000321: ClearLine MD Disposable Cartridge with Collection Bag (the new product name of AirPurge System -