Shape II System Refurbished

GUDID B2009012

Full Shape II system with paramagnetic analyzer

Shape Medical Systems, Inc.

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• Primary Device ID: B2009012
• NIH Device Record Key: e1a684a9-2db6-4409-82b7-4b7422e13c21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shape II System Refurbished
• Version Model Number: 0012-9012
• Company DUNS: 021315587
• Company Name: Shape Medical Systems, 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: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2009012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150888

FDA Product Code

• BTY: Calculator, Predicted Values, Pulmonary Function

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: 2022-04-22
• Device Publish Date: 2022-04-14

Devices Manufactured by Shape Medical Systems, Inc.

• B2009012 - Shape II System Refurbished: 2022-04-22Full Shape II system with paramagnetic analyzer
• B2009012 - Shape II System Refurbished: 2022-04-22 Full Shape II system with paramagnetic analyzer
• B20044012 - Disposable Patient Interface with filter: 2019-05-10 Disposable patient interface with filter 0004-4012
• B20083012 - Shape Vital Sign System: 2019-05-10 Full Shape system with paramagnetic analyzer
• B200HF012 - Shape: 2019-05-10 Paramagnetic Shape analyzer Product 0012
• B20040011 - Shape: 2018-07-06 Shape DPI
• B20044001 - Shape-HF: 2018-07-06 Disposable Patient Interface is part of the Shape-HF testing system
• B20089001 - Shape-HF: 2018-07-06 Shape-HF system
• B200HF001 - Shape-HF: 2018-07-06 Shape-HF analyzer