Shape

GUDID B20040011

Shape DPI

SHAPE MEDICAL SYSTEMS, INC.

Pulmonary function testing kit

• Primary Device ID: B20040011
• NIH Device Record Key: 47bd3263-fb26-420b-bb83-165a641ce3ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shape
• Version Model Number: Shape
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	B20040011 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-14

On-Brand Devices [Shape]

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