Pressure Safe

GUDID 10709078005746

Pressure Safe CO-Flo, Disposable Heated Humidified Circuit Kit

WESTMED, INC.

Oxygen administration kit, non-sterile Oxygen administration kit, non-sterile Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit Oxygen administration kit

• Primary Device ID: 10709078005746
• NIH Device Record Key: 2de4c3f9-716a-4b8c-a41d-c18ceba6aa65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pressure Safe
• Version Model Number: 9655PS
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• 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: true
• Device Combination Product: false
• Single Use: true
• 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	00709078005749 [Primary]
GS1	10709078005746 [Package]; Contains: 00709078005749; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• OGL: Oxygen Administration Kit

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: 2018-07-26
• Device Publish Date: 2018-06-25

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