Transport Kit with Adult Elongated Oxygen Mast

GUDID 10709078004787

WESTMED, INC.

Oxygen administration tubing

• Primary Device ID: 10709078004787
• NIH Device Record Key: 9600dae2-8883-4f02-b547-a15dae77083a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transport Kit with Adult Elongated Oxygen Mast
• Version Model Number: 9439
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00709078004780 [Primary]
GS1	10709078004787 [Package]; Contains: 00709078004780; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904538

FDA Product Code

• CAI: Circuit, Breathing (W Connector, Adaptor, Y Piece)
• OGL: Oxygen Administration Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-24
• Device Publish Date: 2018-05-16

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