BIOPHEN™ V-L Plasma Calibrator 222401

GUDID 03663537019074

HYPHEN BIOMED

Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control Activated protein C resistant factor V (factor V Leiden) IVD, control

• Primary Device ID: 03663537019074
• NIH Device Record Key: e0f75900-2215-4b0c-b904-dc9b7caf61ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOPHEN™ V-L Plasma Calibrator
• Version Model Number: 222401
• Catalog Number: 222401
• Company DUNS: 503499167
• Company Name: HYPHEN BIOMED
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663537019074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083729

FDA Product Code

• JIT: Calibrator, Secondary

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: 2020-08-21
• Device Publish Date: 2016-08-25

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• 03663537084843 - Imidazole buffer: 2020-11-05
• 03663537008320 - BIOPHEN™ V-L Control Plasma: 2020-08-21
• 03663537019074 - BIOPHEN™ V-L Plasma Calibrator: 2020-08-21
• 03663537019074 - BIOPHEN™ V-L Plasma Calibrator: 2020-08-21
• 03663537008047 - Imidazole buffer: 2020-07-08
• 03663537008450 - Calcium chloride 0.025M (M/40): 2020-07-08
• 03663537008467 - Calcium chloride 0.025M (M/40): 2020-07-08