Pantex

Basic Information

• Brand Name: Pantex
• Primary DI: 00850039602689
• Version / Model: N/A
• Catalog Number: 16465-260
• Company Name: Pantex
• Labeler DUNS: 072296809
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-23
• Public Version: 4
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 3edfbdb3-5e3f-4481-9289-149c838f21bf

Device Description

Pantex Sample Collection Device single

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• 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
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65455	Saliva collection mouthpiece IVD	A hand-held intraoral device intended to be used by a layperson in the home to help with the self-collection of a saliva/oral fluid specimen (passive drool) for diagnostic testing or screening purposes (e.g., COVID-19 test). It is in the form of a tubular mouthpiece inserted between the lips to help the patient guide saliva into a collection receptacle (not included) at the distal end. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850039602689	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius