Shape

GUDID B200HF012

Paramagnetic Shape analyzer Product 0012

SHAPE MEDICAL SYSTEMS, INC.

Pulmonary function analysis system, adult

• Primary Device ID: B200HF012
• NIH Device Record Key: b71ff571-6b86-4e57-97aa-90c5a6ca2ce5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shape
• Version Model Number: HF012
• 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: false
• Serial Number: true
• 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	B200HF012 [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: 2019-05-10
• Device Publish Date: 2019-05-02

On-Brand Devices [Shape ]

• B20040011: Shape DPI
• B200HF012: Paramagnetic Shape analyzer Product 0012