PCD Hip 20402

GUDID 00817369022495

PCD Bilateral Hip

NORMATEC INDUSTRIES LP

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

• Primary Device ID: 00817369022495
• NIH Device Record Key: 1616f807-497d-4850-a7e6-a2786c6a66b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PCD Hip
• Version Model Number: PCD Bilateral Hip
• Catalog Number: 20402
• 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	00817369022495 [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

Devices Manufactured by NORMATEC INDUSTRIES LP

• 00810050281294 - NormaTec: 2023-06-26
• 00810050281720 - NormaTec: 2023-06-26
• 00810050281768 - NormaTec: 2023-06-26
• 00810050281782 - NormaTec: 2023-06-26
• 00810050281805 - NormaTec: 2023-06-26
• 00810050281829 - NormaTec: 2023-06-26
• 00810050281836 - NormaTec: 2023-06-26
• 00810050281881 - NormaTec: 2023-06-26