INNOVAC

Basic Information

• Brand Name: INNOVAC
• Primary DI: 00857182006104
• Version / Model: 15-500
• Catalog Number: 15-500
• Company Name: INNOVATIVE MEDICAL TECHNOLOGIES, INC
• Labeler DUNS: 792740578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 5
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: f005731e-26ac-49a8-bdeb-afcba7c5e36a

Device Description

INNOVAC VACUUM HANDLE

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62300	Capillary blood pump IVD	A portable, electrically-powered device designed to generate a vacuum to facilitate the aspiration of blood from a capillary puncture site (e.g., finger, heel) to a capillary blood transfer/collection tube. Blood is guided into the capillary transfer/collection tube through a disposable attachment (e.g., collection funnel) or a side extension of the transfer/collection tube. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857182006104	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K972969	000