NormaTec

GUDID 00810050282116

NORMATEC INDUSTRIES LP

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 00810050282116
• NIH Device Record Key: 64c68aa5-a4ba-4afd-b01d-69d8430cc5b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NormaTec
• Version Model Number: Normatec 3 Leg Attachment - Tall (Single)/REJ6
• 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: true
• 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
GS1	00810050282116 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183328

FDA Product Code

• IRP: Massager, Powered Inflatable Tube
• JOW: Sleeve, Limb, Compressible

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: 2023-06-26
• Device Publish Date: 2023-06-16

On-Brand Devices [NormaTec]

• 00810050283793: The Normatec Go is a powered inflatable tube massager. It is intended to temporarily relieve min
• 00810050283700: The Normatec Go is a powered inflatable tube massager. It is intended to temporarily relieve min
• 00810050282277: Normatec 3/REJ6/Control Unit Basics
• 00810050282123: Normatec 3 Leg Attachment - Tall (Pair)/ REJ6
• 00810050282116: Normatec 3 Leg Attachment - Tall (Single)/REJ6
• 00810050282093: Normatec 3 Leg Attachment - Standard (Pair)/ REJ6
• 00810050281980: The Normatec 3 is a powered air pressure inflatable tube massager. It is intended to temporarily
• 00810050281959: Normatec 3 Leg Attachment - Tall Power (Pair)/REJ6
• 00810050281942: Normatec 3 Leg Attachment - Tall Power (Single)/ R
• 00810050281928: Normatec 3 Leg Attachment - Standard Power (Pair)/
• 00810050281911: Normatec 3 Leg Attachment - Standard Power (Single
• 00810050281898: Normatec 3 Leg Attachment - Short Power (Pair)
• 00810050281881: Normatec 3 Leg Attachment - Short Power (Single)/R
• 00810050281836: Normatec 3 Leg Attachment - Short (Pair)/ REJ6
• 00810050281829: Normatec 3 Leg Attachment - Short (Single)/REJ6
• 00810050281805: Normatec 3 Arm Attachment/REJ 6
• 00810050281782: Normatec 3 Arm Attachment (Pair)/REJ 6
• 00810050281768: Normatec 3/REJ6 Hip Attachment
• 00810050281720: Normatec 3 Leg Attachment - Standard (Single)/REJ6
• 00810050281294: Hyperice X - Knee
• 00810050286084: Normatec Elite tall leg system is a powered air pressure inflatable tube massager. It is intende
• 00810050286077: Normatec Elite short leg system is a powered air pressure inflatable tube massager. It is intend
• 00810050281997: Normatec 3 is a powered air pressure inflatable tube massager. It is intended to temporarily re
• 00810050286053: Normatec Elite standard leg system is a powered air pressure inflatable tube massager. It is int
• 00810050281812: Normatec right arm attachment
• 00810050281713: Normatec Hose Attachment