L-Dex® U400 242-LDEXU400

GUDID B227252LDEXU4002

BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by appl

IMPEDIMED LIMITED

Bioelectrical body composition analyser

• Primary Device ID: B227252LDEXU4002
• NIH Device Record Key: ef077284-d411-479e-88cd-87ad7de85bfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-Dex® U400
• Version Model Number: U400
• Catalog Number: 242-LDEXU400
• Company DUNS: 757258843
• Company Name: IMPEDIMED LIMITED
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61738603700
• Email: XX@XX.com
• Phone: +61738603700
• Email: XX@XX.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B227252LDEXU4002 [Package]; Contains: B277252LDEXU4001; Package: Shipper [1 Units]
HIBCC	B277252LDEXU4000 [Primary]
HIBCC	B277252LDEXU4001 [Package]; Contains: B277252LDEXU4000; Package: Soft Carry Case [1 Units]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130338

FDA Product Code

• OBH: Monitor, Extracellular Fluid, Lymphedema, Extremity

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: 2017-02-13

On-Brand Devices [L-Dex® U400]

• B227252LDEXU4002: BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasiv
• B277242LDEXU4002: BIS Extra Cellular Fluid Analysis- refurbished. It is designed to provide real-time, noninvasiv
• B277222LDEXU4002: BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-