StatStrip 42173

GUDID 00385480421737

StatStrip StatStrip Xpress GLU Linearity Level 1-5

NOVA BIOMEDICAL CORPORATION

Glucose IVD, control

• Primary Device ID: 00385480421737
• NIH Device Record Key: 82a7bf05-d5f5-4c20-8196-732e59b0df25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatStrip
• Version Model Number: Statstrip/StatStrip Xpress
• Catalog Number: 42173
• Company DUNS: 070617139
• Company Name: NOVA BIOMEDICAL CORPORATION
• Device Count: 5
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)545-6682
• Email: info@novabio.com
• Phone: +1(800)545-6682
• Email: info@novabio.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not refrigerate

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480421737 [Primary]
GS1	00385489421738 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150461

FDA Product Code

• JJX: Single (specified) analyte controls (assayed and unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [StatStrip]

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• 00385480547901: Statstrip Glucose Meter with Battery and Quick Reference Guide
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• 00385480533980: Statstrip Glucose Meter with Battery and Quick Reference Guide
• 10385480517079: StatStrip GLU Meter with Quick Reference Guide Remanufactured
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• 10385480474884: StatStrip LAC Meter with Battery and Quick Reference Guide
• 10385480471432: StatStrip Glu Meter and Quick Reference Guide Remanufactured
• 10385480467992: StatStrip Xpress GLU Meter with Battery and Quick Reference Guide
• 10385480458860: StatStrip GLU Meter with Quick Reference Guide Remanufactured
• 10385480449936: StatStrip Glucose Meter With Battery and Quick Reference Guide
• 00385480443753: CAPILLARY TUBES 5uL-50 COUNT HOSPITAL METER
• 10385480437735: StatStrip GLU Meter and Quick Reference Guide Remanufactured
• 10385480434048: StatStrip Xpress Glucose Meter and Quick Reference Guide
• 10385480422243: StatStrip Glucose Meter With Battery and Quick Reference Guide
• 00385480421737: StatStrip StatStrip Xpress GLU Linearity Level 1-5
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