Pressure Safe

GUDID 10709078005746

Pressure Safe CO-Flo, Disposable Heated Humidified Circuit Kit

WESTMED, INC.

Oxygen administration kit, non-sterile

• 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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