Shikani HME Oxygen Tube

GUDID 00866035000350

Airway Company, The

Oxygen administration tubing

• Primary Device ID: 00866035000350
• NIH Device Record Key: 301544a3-f6d5-451b-a9f3-7599bb1beaf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shikani HME Oxygen Tube
• Version Model Number: S-HME O2
• Company DUNS: 063502758
• Company Name: Airway Company, The
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866035000350 [Primary]

FDA Product Code

• BYX: Tubing, Pressure And Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-03
• Device Publish Date: 2019-05-24

Devices Manufactured by Airway Company, The

• 00866035000305 - Shikani Speaking Valve: 2019-06-03
• 00866035000312 - Shikani Speaking Valve: 2019-06-03
• 00866035000343 - Shikani HME: 2019-06-03
• 00866035000350 - Shikani HME Oxygen Tube: 2019-06-03
• 00866035000350 - Shikani HME Oxygen Tube: 2019-06-03