Panther Fusion®

Basic Information

• Brand Name: Panther Fusion®
• Primary DI: 15420045510920
• Version / Model: SPECIMEN TRANSPORT MEDIUM
• Catalog Number: PRD-04423
• Company Name: Hologic, Inc.
• Labeler DUNS: 050579217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-28
• Public Version: 1
• Public Version Date: 2023-12-06
• Public Version Status: New
• Public Device Record Key: 8784b872-845b-4a61-acad-acbee7b1d775

Device Description

Specimen Transport Medium.

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General purpose reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
66118	Microbiological transport medium IVD	A medium in powder, liquid, broth or gel form, commonly available in a tub or bottle from which aliquots can be prepared, intended to be used to maintain the viability of microorganisms suspected of being present in a clinical specimen during its transport prior to in vitro diagnostic analysis and/or culture. It has a non-nutritive composition with or without indicator and may include types such as Amies, anaerobic, Carey-Blair, Stuart, and viral transport/inactivation mediums. This device is not a specimen collection tube/container (i.e., is not intended to directly accept a specimen), and does not include patient-contact specimen sampling/extraction devices such as swabs/brushes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15420045510920	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius