Oxyless

GUDID 15060493650009

The Oxyless blood tubing set comprises disposable blood tubing lines intended to provide extra-corporeal access to the patient's blood during hemodialysis.

OXYLESS LIMITED

Haemodialysis blood tubing set, single-use

• Primary Device ID: 15060493650009
• NIH Device Record Key: e3aae127-4699-4242-bcfd-0ddce3320c1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxyless
• Version Model Number: CK84/14-F
• Company DUNS: 218635156
• Company Name: OXYLESS LIMITED
• 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 Dimensions

• Total Volume: 146 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 34 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060493650002 [Primary]
GS1	15060493650009 [Package]; Contains: 05060493650002; Package: Box [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150304

FDA Product Code

• FJK: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-10-24