ACCUNIQ

GUDID 08805116000157

SELVAS Healthcare, Inc.

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
• 08805116000560: ACCUNIQ BC390