PCD Boot 20115

GUDID 00817369022402

4 Cell XL Zippered Boot

NORMATEC INDUSTRIES LP

Sequential venous compression system Sequential venous compression system Sequential venous compression system

• Primary Device ID: 00817369022402
• NIH Device Record Key: 6c9b6e7c-8fad-4715-aa5a-d37d014a76d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCD Boot
• Version Model Number: 4 Cell XL Zippered Boot
• Catalog Number: 20115
• Company DUNS: 111448069
• Company Name: NORMATEC INDUSTRIES LP
• 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817369022402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161346

FDA Product Code

• JOW: Sleeve, Limb, Compressible

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: 2016-11-07

On-Brand Devices [PCD Boot]

• 00817369022457: OS1-29 4 Cell Custom Boot
• 00817369022440: OS1-26 4 Cell Custom Boot
• 00817369022433: OS1-23 4 Cell Custom Boot
• 00817369022426: 5 Cell XL Zippered Boot
• 00817369022419: 5 Cell Standard Zippered Boot
• 00817369022402: 4 Cell XL Zippered Boot
• 00817369022396: 4 Cell Standard Zippered Boot
• 00817369022389: 3 Cell Zippered Boot