B-Smart

GUDID 18053676290014

B-Smart nerve-block injection pressure manometer

HMC PREMEDICAL SPA

Nerve-block injection manometer

• Primary Device ID: 18053676290014
• NIH Device Record Key: a957963e-5fc8-449a-96ac-c5bfc471a933
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B-Smart
• Version Model Number: BS015-30
• Company DUNS: 429151652
• Company Name: HMC PREMEDICAL SPA
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781.871.7882
• Email: info@concertmedical.com
• Phone: 781.871.7882
• Email: info@concertmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053676290014 [Primary]
GS1	38053676290018 [Package]; Package: Base box [25 Units]; In Commercial Distribution
GS1	58053676290012 [Package]; Contains: 38053676290018; Package: Carton box [11 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031128

FDA Product Code

• CAZ: Anesthesia Conduction Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-04