BioImp Body Composition Analysis Software SFB7 293-SFB7CD

GUDID B277293SFB7CD0

Bio Impedence analysis software US

IMPEDIMED LIMITED

Bioelectrical body composition analyser

• Primary Device ID: B277293SFB7CD0
• NIH Device Record Key: 5f1628bd-7aa5-4b1e-bf83-d9b034892322
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioImp Body Composition Analysis Software SFB7
• Version Model Number: 5.5.0
• Catalog Number: 293-SFB7CD
• 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: false
• 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: 877-247-0111
• Email: XX@xx.xx
• Phone: 877-247-0111
• Email: XX@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B277293SFB7CD0 [Primary]
HIBCC	B277293SFB7CD1 [Package]; Package: CD Sleeve [1 Units]; In Commercial Distribution

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 [BioImp Body Composition Analysis Software SFB7 ]

• B277299SFB7CD1: Bio Impedance analysis software ROW
• B277293SFB7CD0: Bio Impedence analysis software US