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

• 00810050855631 - ThermoFlo®: 2024-12-16 ThermoFlo Trach, Heat and Moisture Condenser - Manufactured By Ningbo Boya
• 10810050855669 - ThermoFlo®: 2024-11-28 CircuitGuard ThermoFlo 1 Filter - Combined HME, Bacterial Viral Filter w O2 Port (Kung Shin)
• 20810050855673 - Microscope Slides: 2024-11-26 Premium Microscope Slides for Roche Ventana, 90° Ground Edges
• 00810050855624 - ThermoFlo®: 2024-11-22 ThermoFlo® Neo, Heat and Moisture Condenser for Neonatal
• 00810050855648 - Rad Control: 2024-07-23 25 Gy Universal Irradiation Tag (RT0301XVT)
• 26941850890275 - Anesthesia Breathing Circuit Kit: 2024-05-16 Adult Anesthesia Breathing Circuit Kit - 90" Dual Limb Breathing Circuit - Bacterial Viral Filter - Size 5 Anesthesia Mask - 3L
• 00810050855488 - Tourniquets: 2024-05-03 Tourniquet 1" x 18", Textured, Rolled & Banded, Blue
• 00810050855501 - Tourniquets: 2024-05-03 Tourniquet 3/4" x 18", Textured, Rolled & Banded, Blue