belter

GUDID 26947468500384

Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Bioelectrical body composition analyser

• Primary Device ID: 26947468500384
• NIH Device Record Key: 74d887de-f6e4-40b2-a03e-871f4a379eb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: belter
• Version Model Number: SF-371
• Company DUNS: 529903321
• Company Name: Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06947468500380 [Primary]
GS1	16947468500387 [Package]; Contains: 06947468500380; Package: 1pcs/box [1 Units]; In Commercial Distribution
GS1	26947468500384 [Package]; Contains: 16947468500387; Package: 5pcs/box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122976

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: 2017-01-09

On-Brand Devices [belter]

• 26947468500384: SF-371
• 16947468500011: TE-91
• 16947468500042: TE-93
• 16947468500080: Blood Pressure Meter
• 06947468500373: Body temperature