StatStrip 63685
GUDID 00385480636858
StatStrip Glucose Hospital Meter System
NOVA BIOMEDICAL CORPORATION
Glucose monitoring system IVD, point-of-care| Primary Device ID | 00385480636858 |
| NIH Device Record Key | 2a2c34df-2b1c-4418-b695-42085c133ef7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StatStrip |
| Version Model Number | 63685 |
| Catalog Number | 63685 |
| Company DUNS | 070617139 |
| Company Name | NOVA BIOMEDICAL CORPORATION |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com | |
| Phone | +18005456682 |
| info@novabio.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
| Special Storage Condition, Specify | Between 0 and 0 *Relative Humidity: Up to 90% (noncondensing) |
| Special Storage Condition, Specify | Between 0 and 0 *Altitude: Up to 15,000 feet |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00385480636858 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232075
FDA Product Code
| PZI | Prescription use blood glucose meter for near-patient testing |
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 | 2024-04-05 |
| Device Publish Date | 2024-03-28 |
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 |
Trademark Results [StatStrip]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STATSTRIP 78603247 not registered Dead/Abandoned |
Nova Biomedical Corporation 2005-04-06 |
 STATSTRIP 78603189 3442301 Live/Registered |
Nova Biomedical Corporation 2005-04-06 |
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