STATSTRIP 47552

GUDID 00385480475525

Nova StatStrip LAC Linearity, Level 1, Level 2, Level 3, Level 4

NOVA BIOMEDICAL CORPORATION

Lactate IVD, control

• Primary Device ID: 00385480475525
• NIH Device Record Key: 93f97d57-5723-4aea-a41c-d06e78d40204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STATSTRIP
• Version Model Number: Lactate
• Catalog Number: 47552
• Company DUNS: 070617139
• Company Name: NOVA BIOMEDICAL CORPORATION
• Device Count: 4
• 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

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385480475525 [Primary]
GS1	00385489475526 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112955

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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: 2016-09-16

On-Brand Devices [STATSTRIP]

• 10385480565100: StatStrip Xpress2 GLU Meter with Battery and Quick Reference Guide
• 00385480547901: Statstrip Glucose Meter with Battery and Quick Reference Guide
• 00385480533997: Statstrip Glucose Meter with Battery and Quick Reference Guide Remanufactured
• 00385480533980: Statstrip Glucose Meter with Battery and Quick Reference Guide
• 10385480517079: StatStrip GLU Meter with Quick Reference Guide Remanufactured
• 00385480475525: Nova StatStrip LAC Linearity, Level 1, Level 2, Level 3, Level 4
• 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
• 00385480412247: Safety Lancets 28-Gauge 100 Pack Boxed
• 00385480636858: StatStrip Glucose Hospital Meter System