B-Smart

Basic Information

• Brand Name: B-Smart
• Primary DI: 18053676290014
• Version / Model: BS015-30
• Company Name: HMC PREMEDICAL SPA
• Labeler DUNS: 429151652
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a957963e-5fc8-449a-96ac-c5bfc471a933

Device Description

B-Smart nerve-block injection pressure manometer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAZ	Anesthesia Conduction Kit	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61722	Nerve-block injection manometer	A sterile, noninvasive, non-powered (passive) device intended to be connected between a syringe and a nerve-block needle (e.g., fitted to anaesthesia delivery tubing) to indicate injection pressure during administration of local or regional anaesthesia to achieve peripheral nerve blockade. It is intended to provide qualitative feedback (e.g., via a traffic light indicator) to the healthcare professional so that corrective measures can be taken for undesirable pressures (e.g., high injection pressure may indicate undesirable needle tip placement). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18053676290014	GS1
Package	38053676290018	GS1	Base box	25	In Commercial Distribution
Package	58053676290012	GS1	Carton box	11	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K031128	000