LabChoice Midstream Specimen Catch Kit, Sterile

GUDID 00840117338029

Content List: 4 oz Graduated Specimen Container, Protective Collar, Screw-on Lid, Patient Label, 3 BZK Towelettes, Instructions for use. STERILE-EO

Dynarex Corporation

General specimen collection kit

• Primary Device ID: 00840117338029
• NIH Device Record Key: cbada2a6-9490-4009-8eee-9d9f8c2794df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LabChoice Midstream Specimen Catch Kit, Sterile
• Version Model Number: 43028
• Company DUNS: 008124539
• Company Name: Dynarex Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117329492 [Package]; Package: Case [100 Units]; In Commercial Distribution
GS1	00840117338029 [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: 2025-03-24
• Device Publish Date: 2025-03-14

Devices Manufactured by Dynarex Corporation

• 00840117329775 - LabChoice Electronic Pipette Single Channel, Adjustable Volume 5-50 uL: 2025-04-03
• 00810180841580 - LabChoice Rigid Inoculation Loops, Blue, Sterile, 10ul: 2025-03-31 STERILE-R
• 00810180841597 - LabChoice Flexible Inoculation Loops, Blue, Sterile, 10 ul: 2025-03-31 STERILE-R
• 00840117340688 - Biopsy Punch, Sterile, 1.5 mm ,White: 2025-03-28
• 00840117340695 - Biopsy Punch, Sterile, 2.0 mm, Ivory: 2025-03-28
• 00840117340701 - Biopsy Punch, Sterile, 2.5 mm, Green: 2025-03-28
• 00810180841566 - LabChoice Rigid Inoculation Loops, Transparent, Sterile, 1 ul: 2025-03-24 STERILE-R
• 00810180841573 - LabChoice Flexible Inoculation Loops, White, Sterile, 1 uL: 2025-03-24