EvaQMax Laparo

Basic Information

• Brand Name: EvaQMax Laparo
• Primary DI: 08809083944827
• Version / Model: ASFN3
• Company Name: BIOPROTECH INC.
• Labeler DUNS: 688460539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-28
• Public Version: 1
• Public Version Date: 2024-09-05
• Public Version Status: New
• Public Device Record Key: 85cb15a1-6ef3-42f9-a107-be202387b49d

Device Description

Active In line Fluid Trap & Filter, Active Laparoscopic Smoke Evacuation Device, Filtration, Fluid trap, 10 Ft(3M) hose

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: Yes
• 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: Yes
• 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
GAZ	Tubing, Noninvasive	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46483	Surgical plume evacuation system tube	A long, hollow cylinder which, as part of a surgical plume evacuation system, is intended to be used to capture, conduct, and exhaust the plume of smoke generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	18809083944824	GS1	Inner Box	10	In Commercial Distribution
Primary	08809083944827	GS1
Package	28809083944821	GS1	Carton	4	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius