ACCUNIQ

GUDID 08805116000157

SELVAS Healthcare, Inc.

Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser Bioelectrical body composition analyser

• Primary Device ID: 08805116000157
• NIH Device Record Key: 6b91b38d-c973-47eb-ad5a-75f8f755984a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCUNIQ
• Version Model Number: ACCUNIQ BC310
• Company DUNS: 689700711
• Company Name: SELVAS Healthcare, Inc.
• 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: 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

Customer Support Contacts

• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com
• Phone: +82428793024
• Email: daisy.j.yoon@selvashc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08805116000157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140045

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: 2
• Public Version Date: 2023-06-12
• Device Publish Date: 2019-02-01

On-Brand Devices [ACCUNIQ]

• 08805116000379: ACCUNIQ BP850
• 08805116000317: ACCUNIQ BP250
• 08805116000300: ACCUNIQ BP210
• 08805116000454: EV360
• 08805116000164: ACCUNIQ BC300
• 08805116000157: ACCUNIQ BC310
• 08805116000140: ACCUNIQ BC360
• 08805116000133: ACCUNIQ BC380
• 08805116000119: ACCUNIQ BC720