Shape-HF

GUDID B20089001

Shape-HF system

SHAPE MEDICAL SYSTEMS, INC.

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• Primary Device ID: B20089001
• NIH Device Record Key: 2a1293ab-001e-493e-b15b-b645d9933192
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shape-HF
• Version Model Number: 0008-9001
• 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	B20089001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090722

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-26

On-Brand Devices [Shape-HF]

• B200HF001: Shape-HF analyzer
• B20089001: Shape-HF system
• B20044001: Disposable Patient Interface is part of the Shape-HF testing system