Salimetrics

Basic Information

• Brand Name: Salimetrics
• Primary DI: 00859410006351
• Version / Model: N/A
• Catalog Number: 5016.04
• Company Name: SALIMETRICS, LLC
• Labeler DUNS: 084843064
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-10
• Public Version: 1
• Public Version Date: 2025-12-18
• Public Version Status: New
• Public Device Record Key: 0f73abe9-355f-4807-a32a-297f3d5421c6

Device Description

Saliva Collection Aid PK/50

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	864.3250	1

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	00859410006351	GS1