Novo Vivo

Basic Information

• Brand Name: Novo Vivo
• Primary DI: 00736239051000
• Version / Model: 05100
• Catalog Number: 05100
• Company Name: Genesis Industries, Incorporated
• Labeler DUNS: 157053026
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-12
• Public Version: 1
• Public Version Date: 2023-09-20
• Public Version Status: New
• Public Device Record Key: 7ccb3e56-7449-4235-8c99-0a6f1c97f38b

Device Description

Novo Vivo Suction Catheter

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: 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
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
30882	Assisted reproduction transfer catheter trial	A flexible polymer tube intended to be used to simulate the transvaginal insertion of an assisted reproduction catheter set for embryo transfer, to assess advancement through the cervical canal and the position of the uterus. It typically consists of an inner and outer catheter (or catheter sheath) identical to the devices used for the transfer procedure, except that the inner catheter has a rounded blind/closed distal end. This device cannot be used for the introduction of embryos or other reproductive materials into the cervical canal or uterine cavity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00736239051000	GS1