STA Compact Max® (with cap piercing option)

GUDID 03607450589894

DIAGNOSTICA STAGO

Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory

• Primary Device ID: 03607450589894
• NIH Device Record Key: 475d4cc6-524d-44c8-9970-0592ae27b50e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STA Compact Max® (with cap piercing option)
• Version Model Number: 58989
• Company DUNS: 262277122
• Company Name: DIAGNOSTICA STAGO
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03607450589894 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093167

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-09-16
• Device Publish Date: 2016-09-15

Devices Manufactured by DIAGNOSTICA STAGO

• 03607450581041 - STA Satellite®: 2022-09-16
• 03607450589788 - STA-R Evolution® Expert Series: 2022-09-16
• 03607450589795 - STA-R Evolution® Expert Series (with cap piercing option): 2022-09-16
• 03607450589894 - STA Compact Max® (with cap piercing option): 2022-09-16
• 03607450589894 - STA Compact Max® (with cap piercing option): 2022-09-16
• 03607450589900 - STA Compact Max®: 2022-09-16
• 03607450590104 - STA R Max® (with cap piercing option): 2022-09-16
• 03607450590135 - STA R Max®: 2022-09-16
• 03607450590265 - STA R Max®: 2022-09-16