PADnet

GUDID 00862467000302

Collaborative Care Diagnostics LLC

Limb plethysmograph

• Primary Device ID: 00862467000302
• NIH Device Record Key: 9c8b4f3a-098d-4122-b7c4-7d7b944f060f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PADnet
• Version Model Number: 2.0
• Company DUNS: 029870178
• Company Name: Collaborative Care Diagnostics LLC
• 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
GS1	00862467000302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122281

FDA Product Code

• JOM: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

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: 2016-09-24