Typesafe

GUDID 00812269031295

Typesafe Segment Piercing Device

TYPENEX MEDICAL LLC

Blood donor bag segment sampling IVD

• Primary Device ID: 00812269031295
• NIH Device Record Key: 2a8fffa0-3510-48c5-8895-525533a119d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typesafe
• Version Model Number: 4R4750
• Company DUNS: 600850213
• Company Name: TYPENEX MEDICAL LLC
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812269031288 [Unit of Use]
GS1	00812269031295 [Package]; Contains: 10812269031285; Package: Master Carton [2 Units]; In Commercial Distribution
GS1	10812269031285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK070037

FDA Product Code

• KSS: Supplies, Blood-Bank

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: 2022-11-29
• Device Publish Date: 2022-11-21

On-Brand Devices [Typesafe]

• 00812269031295: Typesafe Segment Piercing Device
• 20812269031275: Typesafe Segment Piercing Device