CultureSafe

GUDID 10810050855256

Blood Culture Bottle Dispensing Device

TYPENEX MEDICAL LLC

Blood/blood culture specimen transfer spike IVD

• Primary Device ID: 10810050855256
• NIH Device Record Key: c7b263f8-e972-4737-aa75-76fce374fbde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CultureSafe
• Version Model Number: AW0101
• Company DUNS: 600850213
• Company Name: TYPENEX MEDICAL LLC
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810050855259 [Primary]
GS1	10810050855256 [Package]; Contains: 00810050855259; Package: Inner Case [60 Units]; In Commercial Distribution
GS1	20810050855253 [Package]; Package: Outer Case [360 Units]; In Commercial Distribution

FDA Product Code

• LIB: Device, General Purpose, Microbiology, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-27
• Device Publish Date: 2023-06-19

Devices Manufactured by TYPENEX MEDICAL LLC

• 10810050855782 - Fibernex Laser System: 2025-08-05 Fibernex Go Laser System
• 20810050855772 - Microscope Slides: 2025-07-22 Liquid Based Cytology Slides, Uncoated, Single Circle, Ground Edge, 45° Corners, Blue (LC0104B)
• 20810050855765 - Microscope Slides: 2025-07-16 Premium Microscope Slide, Ground Edges, 45° Corners, White (PS0204W)
• 20810050855741 - Microscope Slides: 2025-06-25 Premium Microscope Slide, Positive Charged, Thermal Printing, Ground Edges, 45° Corners - White Frosted (PS0404WXT)
• 20810050855758 - Microscope Slides: 2025-06-25 Premium Microscope Slide, Positive Charged, Thermal Printing, Ground Edges, 45° Corners - Yellow Frosted (PS0404YXT)
• 00810050855457 - Rad Control: 2025-06-02 15 Gy Universal Irradiation Tag
• 00810050855471 - Rad Control: 2025-06-02 25 Gy Universal Irradiation Tag
• 20810050855697 - Microscope Sldies: 2025-02-11 Liquid Based Cytology Slides, Single Printed Circle, Ground Edge 45° Corners