SalivaBio 5001.06

GUDID 00859410006207

SalivaBio Children's Swab (SCS) PK/50

SALIMETRICS, LLC

Oral/upper respiratory tract specimen collection swab IVD

• Primary Device ID: 00859410006207
• NIH Device Record Key: 2b790956-55ec-491b-9dcd-aea60fe48c39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SalivaBio
• Version Model Number: N/A
• Catalog Number: 5001.06
• 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	00859410006207 [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