Hemotec Whole Blood Control Kit Large

GUDID 00817869020311

ANALYTICAL CONTROL SYSTEMS INC

Activated clotting time (ACT) IVD, control

• Primary Device ID: 00817869020311
• NIH Device Record Key: bc6c0731-21a0-4329-89ae-8e237534f713
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hemotec Whole Blood Control Kit Large
• Version Model Number: SC-125, SC-126, H2O
• Company DUNS: 038232682
• Company Name: ANALYTICAL CONTROL SYSTEMS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	00817869020311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925340

FDA Product Code

• JPA: System, Multipurpose For In Vitro Coagulation Studies

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: 2019-08-01
• Device Publish Date: 2019-07-24

On-Brand Devices [Hemotec Whole Blood Control Kit Large]

• 00817869020335: Whole Blood Control Kit containing 8 vials of each: SC-125, SC-126, and DW-101
• 00817869020311: SC-125, SC-126, H2O