Imp DF50 229-DF50

GUDID B277259DF502

DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare

IMPEDIMED LIMITED

Bioelectrical body composition analyser

• Primary Device ID: B277259DF502
• NIH Device Record Key: cd9f5176-0d32-4111-be57-f7c1fd92bf88
• Commercial Distribution Discontinuation: 2017-02-13
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Imp DF50
• Version Model Number: DF50
• Catalog Number: 229-DF50
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B277259DF500 [Primary]
HIBCC	B277259DF501 [Package]; Contains: B277259DF500; Package: Soft Carry Case [1 Units]; Discontinued: 2017-02-13; Not in Commercial Distribution
HIBCC	B277259DF502 [Package]; Contains: B277259DF500; Package: Shipper [1 Units]; Discontinued: 2017-02-13; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050395

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 DF50]

• B277259DF502: DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
• B277253DF502: DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
• B277249DF502: DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
• B277243DF502: DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
• B277229DF502: DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen
• B277223DF502: DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessmen