Autoclavable version of Fg5 EB

Basic Information

• Brand Name: Autoclavable version of Fg5 EB
• Primary DI: 03701354401013
• Version / Model: Fg5 EB/A
• Company Name: PLASMABIOTICS
• Labeler DUNS: 262972663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-13
• Public Version: 1
• Public Version Date: 2021-05-21
• Public Version Status: New
• Public Device Record Key: c31ee692-c379-4835-bed3-db38f1523767

Device Description

Autoclavable version of Fg5 EB

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61445	Endoscope clean-storage system	A mobile, mains electricity (AC-powered) assembly of devices intended to prepare, bag, label and register disinfected and sterilized endoscopes prior to long-term storage. It typically includes: 1) a fluid preparation assembly such as fluid pump, tubing and a preparation solution (e.g., hydrogen peroxide solution); 2) devices intended to achieve sealed-storage such as trays, sterile liners, vacuum bags, and a vacuum pump; 3) labelling/registration devices (i.e., bar-code printer and bar-code reader); and 4) a computer with integrated software for process/data management. It is not intended to clean, disinfect or sterilize but to maintain the sterilized/disinfected state of the endoscope.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03701354401013	GS1

Device Sizes

Type	Value	Unit	Text
Length	34	Centimeter
Width	23	Centimeter
Height	3	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: .9 – 1.1 Inches of Mercury