GBX Fixer and Replenisher

Basic Information

• Brand Name: GBX Fixer and Replenisher
• Primary DI: 40889971901879
• Version / Model: GBX Fixer and Replenisher
• Catalog Number: 1901875
• Company Name: CARESTREAM HEALTH, INC.
• Labeler DUNS: 793169512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: b64d0cb1-decd-4251-b383-f375d145b70b

Device Description

GBX Fixer and Repl - 1 GL

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWZ	Film, radiographic	Radiology	892.1840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41008	X-ray film processing chemical, manual	A chemical, e.g., a fixer or developer, used in the manual processing of x-ray film or other kinds of radiographic film used in medical applications, e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound and nuclear medicine applications.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	60889971901873	GS1	Case	12	In Commercial Distribution
Primary	40889971901879	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius