INDICAID health Sexual Health 2 DSTD0223, RSTD0223

GUDID 00810113420028

A collection of noninvasive devices intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation.

Phase Diagnostics, Inc.

Urine specimen collection kit IVD

• Primary Device ID: 00810113420028
• NIH Device Record Key: 41cffdc7-5bb0-4489-9ed6-23c80bebb16f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INDICAID health Sexual Health 2
• Version Model Number: DSTD0223, RSTD0223
• Catalog Number: DSTD0223, RSTD0223
• Company DUNS: 078302415
• Company Name: Phase Diagnostics, 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 Identifiers

Device Issuing Agency	Device ID
GS1	00810113420028 [Primary]

FDA Product Code

• OIE: Urine Collection Kit (Excludes Hiv Testing)

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: 2023-10-11
• Device Publish Date: 2023-10-03