BWELL

GUDID 16974239700127

Guangzhou Daxin health technology Co.,Ltd

Bioelectrical body composition analyser

• Primary Device ID: 16974239700127
• NIH Device Record Key: 8ffcfa9e-a338-4766-a9c4-fd4d71b0ebfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BWELL
• Version Model Number: eF-919B4
• Company DUNS: 722481840
• Company Name: Guangzhou Daxin health technology Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974239700120 [Primary]
GS1	16974239700127 [Package]; Contains: 06974239700120; Package: [1 Units]; In Commercial Distribution
GS1	26974239700124 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• PUH: Analyzer, Body Composition, Exempt

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-25
• Device Publish Date: 2022-07-15

Devices Manufactured by Guangzhou Daxin health technology Co.,Ltd

• 16974239700677 - FOXXD: 2024-10-04
• 16974239700660 - Sealy: 2024-09-20
• 16974239700646 - FOXXD: 2024-08-09
• 16974239700653 - FOXXD: 2024-08-09
• 06974239702841 - innotech: 2024-04-05
• 16974239700639 - innotech: 2024-04-05
• 16974239700615 - Bytech: 2024-02-01
• 16974239700608 - Bytech: 2023-12-26