Imp SFB7 253-SFB7

GUDID B277253SBF72

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

IMPEDIMED LIMITED

Bioelectrical body composition analyser

• Primary Device ID: B277253SBF72
• NIH Device Record Key: 3e9f38f4-2342-4fa5-ae2f-73a7eda13b58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Imp SFB7
• Version Model Number: SFB7
• Catalog Number: 253-SFB7
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B277253SBF71 [Package]; Contains: B277253SFB70; Package: Soft Carry Case [1 Units]
HIBCC	B277253SBF72 [Package]; Contains: B277253SBF71; Package: Shipper [1 Units]
HIBCC	B277253SFB70 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052319

FDA Product Code

• MNW: Analyzer, Body Composition

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 [Imp SFB7]

• B277259SFB72: BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
• B277253SBF72: BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
• B277249SFB70: BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
• B277243SFB72: BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
• B277229SFB72: BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-
• B277223SFB72: BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-