STAT PROFILE 53108
GUDID 00385480531085
Prime Auto QC Cartridge ABG 300 Sample
NOVA BIOMEDICAL CORPORATION
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control| Primary Device ID | 00385480531085 |
| NIH Device Record Key | fe0e9e22-9b0c-480d-8c39-8b4d054a40db |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STAT PROFILE |
| Version Model Number | PRIME ABG |
| Catalog Number | 53108 |
| 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 | 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 |
| info@novabio.com | |
| Phone | +1(800)545-6682 |
| info@novabio.com |
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 |
| Handling 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 | 00385480531085 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K151982
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 | 2016-09-20 |
On-Brand Devices [STAT PROFILE]
| 10385480616154 | Stat Profile Prime Plus MicroSensor Card™ with COOX |
| 10385480616147 | Stat Profile Prime Plus MicroSensor Card™ with COOX (High Volume) |
| 10385480595084 | Stat Profile Prime Plus® Analyzer (Remanufactured) |
| 10385480586433 | Stat Profile Prime Plus MicroSensor Card™ (High Volume) |
| 10385480586426 | Stat Profile Prime Plus MicroSensor Card™ |
| 10385480583791 | Stat Profile Prime Plus MicroSensor Card™ BLANK |
| 00385480578455 | Stat Profile Prime Plus Ampuled Controls Chemistry Levels 4,5 |
| 00385480578448 | Stat Profile Prime Plus Ampuled Controls BG, COOX Levels 1, 2, 3 |
| 00385480578431 | Stat Profile Prime Plus Auto QC Cartridge 315 Sample with Creat / BUN |
| 00385480578424 | Stat Profile Prime Plus Auto QC Cartridge 210 Sample with Creat / BUN |
| 00385480578417 | Stat Profile Prime Plus Auto QC Cartridge 105 Sample with Creat / BUN |
| 00385480578400 | Stat Profile Prime Plus Auto QC Cartridge 480 Sample |
| 00385480578394 | Stat Profile Prime Plus Auto QC Cartridge 320 Sample |
| 00385480578387 | Stat Profile Prime Plus Auto QC Cartridge 160 Sample |
| 00385480578356 | Stat Profile Prime Plus Calibrator Cartridge 500 Sample with Creat / BUN |
| 00385480578349 | Stat Profile Prime Plus Calibrator Cartridge 400 Sample with Creat / BUN |
| 00385480578332 | Stat Profile Prime Plus Calibrator Cartridge 300 Sample with Creat / BUN |
| 00385480578325 | Stat Profile Prime Plus Calibrator Cartridge 200 Sample with Creat / BUN |
| 00385480578318 | Stat Profile Prime Plus Calibrator Cartridge 100 Sample with Creat / BUN |
| 00385480578295 | Stat Profile Prime Plus Calibrator Cartridge 500 Sample |
| 00385480578288 | Stat Profile Prime Plus Calibrator Cartridge 400 Sample |
| 00385480578271 | Stat Profile Prime Plus Calibrator Cartridge 300 Sample |
| 00385480578264 | Stat Profile Prime Plus Calibrator Cartridge 200 Sample |
| 00385480578257 | Stat Profile Prime Plus Calibrator Cartridge 100 Sample |
| 00385480578233 | Stat Profile Prime Plus Reference Cartridge |
| 10385480578216 | Stat Profile Prime Plus MicroSensor Card™ BUN, Creatinine |
| 10385480574003 | Stat Profile Prime Plus® Analyzer |
| 00385480567268 | Prime Capillary Tube 150 uL with Balanced Heparin 250 per vial |
| 00385480567251 | Prime Capillary Tube 230 uL with Balanced Heparin 250 per vial |
| 00385480561983 | Linearity Standard Set G Multipack |
| 10385480552643 | Prime Sensor Card CCS Comp (High Volume) |
| 10385480552636 | Prime Sensor Card CCS (High Volume) |
| 10385480552629 | Prime Sensor Card ABG (High Volume) |
| 00385480536677 | Remanufactured Prime CCS Comp w/ Scanner Analyzer |
| 00385480536660 | Remanufactured Prime CCS w/ Scanner Analyzer |
| 00385480536653 | Remanufactured Prime ABG w/ Scanner Analyzer |
| 00385480536578 | Prime CCS Comp w/ Scanner Analyzer |
| 00385480536561 | Prime CCS w/ Scanner Analyzer |
| 00385480536554 | Prime ABG w/ Scanner Analyzer |
| 10385480534694 | Prime Calibrator Cartridge CCS Comp 500 Sample |
| 00385480534673 | Prime Calibrator Cartridge CCS 500 Sample |
| 00385480534666 | Prime Calibrator Cartridge CCS 400 Sample |
| 00385480534642 | Prime Calibrator Cartridge ABG 500 Sample |
| 00385480534635 | Prime Calibrator Cartridge ABG 400 Sample |
| 00385480534567 | Prime Auto QC Cartridge ABG 100 Sample |
| 00385480534550 | Prime Auto QC Cartridge CCS 100 Sample |
| 00385480534215 | Remanufactured PRIME ABG Analyzer |
| 00385480534208 | Remanufactured PRIME CCS Comp Analyzer |
| 00385480534185 | Remanufacture PRIME CCS Analyzer |
| 00385480533652 | Prime Calibrator Cartridge CCS Comp 200 Sample |
Trademark Results [STAT PROFILE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STAT PROFILE 85532383 4420520 Live/Registered |
Nova Biomedical Corporation 2012-02-02 |
 STAT PROFILE 73634700 1453109 Dead/Cancelled |
NOVA BIOMEDICAL CORPORATION 1986-12-11 |
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