Tri-Tech Forensics, Inc.

GUDID 00869373000235

Tri-Tech Forensics Urine Specimen Collection Kit

TRI-TECH FORENSICS, INC.

Urine specimen collection kit IVD

• Primary Device ID: 00869373000235
• NIH Device Record Key: fc4364e8-68cb-4218-a518-9518a771e267
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tri-Tech Forensics, Inc.
• Version Model Number: UC-1
• Company DUNS: 105878292
• Company Name: TRI-TECH FORENSICS, INC.
• 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: true

Device Dimensions

• Length: 5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869373000235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952246

FDA Product Code

• JXA: Kit, Screening, Urine

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: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [Tri-Tech Forensics, Inc.]

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• 00869373000242: Tri-Tech Forensics Custom Sexual Assault Kit
• 00869373000235: Tri-Tech Forensics Urine Specimen Collection Kit
• 00869373000228: Tri-Tech Forensics Custom Blood and Urine Specimen Collection Kit
• 00869373000211: Tri-Tech Forensics Custom Blood Alcohol Kit
• 10869373000201: 10 ml Grey Stoppered Blood Tube, Each