Typesafe 2.0

GUDID 00812269031264

Typesafe 2.0 - Quantity 1000

TYPENEX MEDICAL LLC

Blood donor bag segment sampling IVD

• Primary Device ID: 00812269031264
• NIH Device Record Key: 6182c97b-f570-4a96-883f-097aa807906a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Typesafe 2.0
• Version Model Number: SP0201QM
• 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	00812269031257 [Unit of Use]
GS1	00812269031264 [Package]; Contains: 10812269031254; Package: Carton [2 Units]; In Commercial Distribution
GS1	10812269031254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK150351

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 2.0]

• 00812269031264: Typesafe 2.0 - Quantity 1000
• 00812269031240: Typesafe 2.0 - Quantity 500