SalivaBio 5016.04

GUDID 00859410006009

SalivaBio Saliva Collection Aid PK/50

SALIMETRICS, LLC

Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD Saliva collection mouthpiece IVD

• Primary Device ID: 00859410006009
• NIH Device Record Key: 614be1fc-a93e-4f0f-90ce-25a1a7087c97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SalivaBio
• Version Model Number: N/A
• Catalog Number: 5016.04
• Company DUNS: 084843064
• Company Name: SALIMETRICS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859410006009 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-21
• Device Publish Date: 2022-10-13

On-Brand Devices [SalivaBio]

• 00859410006238: SalivaBio Saliva Collection Aid PK/100
• 00859410006221: SalivaBio Saliva Collection Aid PK/50
• 00859410006214: SalivaBio Saliva Collection Aid PK/100
• 00859410006207: SalivaBio Children's Swab (SCS) PK/50
• 00859410006191: SalivaBio Oral Swab (SOS) PK/50
• 00859410006184: SalivaBio Infant Swab (SIS) PK/50
• 00859410006009: SalivaBio Saliva Collection Aid PK/50