Typesafe

GUDID 20812269031275

Typesafe Segment Piercing Device

TYPENEX MEDICAL LLC

Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD Blood donor bag segment sampling IVD

• Primary Device ID: 20812269031275
• NIH Device Record Key: eed017e2-0757-451b-9d98-f0faf12697b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typesafe
• Version Model Number: TS500
• 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	00812269031271 [Unit of Use]
GS1	10812269031278 [Primary]
GS1	20812269031275 [Package]; Contains: 10812269031278; Package: Carton [1 Units]; In Commercial Distribution

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