DS5

GUDID 00850064651003

Depth Sensor

Foresite Healthcare, LLC

Biomechanical function analysis system, motion-tracking

• Primary Device ID: 00850064651003
• NIH Device Record Key: fba168c5-92f7-4dfd-9fd4-58e9d6e02999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DS5
• Version Model Number: DS5-RN
• Company DUNS: 095335981
• Company Name: Foresite Healthcare, LLC
• 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: 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

Customer Support Contacts

• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com
• Phone: 3149385586
• Email: support@foresitehealthcare.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care
• Special Storage Condition, Specify: Between 0 and 0 *keep dry; handle with care

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850064651003 [Primary]

FDA Product Code

• ISD: Exerciser, Measuring

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: 2024-06-03
• Device Publish Date: 2024-05-24

Devices Manufactured by Foresite Healthcare, LLC

• 00850064651102 - DS6: 2025-02-17 Depth Sensor
• 00850064651003 - DS5: 2024-06-03Depth Sensor
• 00850064651003 - DS5: 2024-06-03 Depth Sensor
• 00850064651010 - DS6: 2024-06-03 Depth Sensor
• 00850064651027 - MDS: 2024-06-03 Mobile Depth Sensor
• 00850064651034 - Bed4: 2024-06-03 Depth Sensor
• 00850064651041 - DS6: 2024-06-03 Depth Sensor
• 00850064651058 - DS6: 2024-06-03 Depth Sensor
• 00850064651065 - DS6: 2024-06-03 Depth Sensor