SmartPractice

Basic Information

• Brand Name: SmartPractice
• Primary DI: 00854634003049
• Version / Model: AL7950
• Catalog Number: AL7950
• Company Name: Smarthealth, Inc.
• Labeler DUNS: 061081477
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-12-04
• Public Version: 2
• Public Version Date: 2022-03-03
• Public Version Status: Update
• Public Device Record Key: cde156ee-eb98-4ce4-852a-c9da74541b1c

Device Description

TruVol 20 microliter Precision Allergen Dispenser, 20-pack

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JRC	Micro Pipette	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42875	Mechanical micropipette	A manually-operated device typically used in the laboratory to withdraw, transfer, and inject minute volumes of fluid materials (e.g., microlitres or smaller). The device is typically hand-held and operates through an internal mechanism powered by finger depressions of the user; it can have a single channel or a multichannel piston/cylinder assembly. The device transfers consistent volumes of substance into one or several receptacles simultaneously. The device may be factory pre-set to deliver a given volume, or may have user-selectable volumes within a useful volume range.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854634003049	GS1
Unit of Use	10854634003046	GS1

Customer Contacts

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