Phoenix Diagnostics 16-202

GUDID 10853366007179

ISE Internal Ref Sol for Roche / Hitachi 700 & 900 Series Chemistry Systems

PHOENIX DIAGNOSTICS, INC.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

• Primary Device ID: 10853366007179
• NIH Device Record Key: 2d68f836-6c0d-49d4-81c8-5bd840e5d487
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phoenix Diagnostics
• Version Model Number: 16-202
• Catalog Number: 16-202
• Company DUNS: 606814960
• Company Name: PHOENIX DIAGNOSTICS, INC.
• 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: 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

Customer Support Contacts

• Phone: 5086558310
• Email: sales@phoenixdiagnostics.com

Device Dimensions

• Total Volume: 2000 Milliliter

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853366007172 [Primary]
GS1	10853366007179 [Package]; Contains: 00853366007172; Package: case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013451

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

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: 2020-03-30
• Device Publish Date: 2017-10-02

On-Brand Devices [Phoenix Diagnostics]

• 10853366007018: ISE Buffer Solution for Olympus AU Series Chemistry Systems
• 00853366007615: Universal Cal Pack (Snap Pack) for Menarini SpotLyte Series Electrolyte Systems
• 00853366007608: Universal Cal Pack (Snap Pack) for Medica EasyLyte Series Electrolyte Systems
• 00853366007486: ISE Reagent Pack for Roche / AVL 9180 & 9181 Series Electrolyte Systems
• 00853366007462: ISE Reagent Pack for Roche / AVL 9120 & 9130 Series Electrolyte Systems
• 10853366007391: Fast Detergent 2 for Tokyo Boeki BiOLiS Series Chemistry Systems
• 10853366007384: Fast Detergent 1 for Tokyo Boeki BiOLiS Series Chemistry Systems
• 00853366007370: Calibrator 2 for Tokyo Boeki BiOLiS Series Chemistry Systems
• 00853366007363: Calibrator 1 for Tokyo Boeki BiOLiS Series Chemistry Systems
• 10853366007292: Na / Cl Calibrator for Roche / Hitachi Chemistry Systems
• 00853366007288: K Calibrator for Roche / Hitachi Chemistry Systems
• 08533660072244: Hitergent for Roche / Hitachi 900 Series
• 10853366007223: ISE Standard High for Roche / Hitachi Chemistry Systems
• 10853366007216: ISE Standard Low for Roche / Hitachi Chemistry Systems
• 00853366007196: ISE 1N KCL Sol for Roche / Hitachi 700 & 900 Series Chemistry Systems
• 10853366007179: ISE Internal Ref Sol for Roche / Hitachi 700 & 900 Series Chemistry Systems
• 10853366007148: ISE Diluent for Roche / Hitachi 704, 902, and P800 Series Chemistry Systems
• 10853366007056: ISE High Serum Standard for Olympus AU Series Chemistry Systems
• 10853366007049: ISE Low Serum Standard for Olympus AU Series Chemistry Systems
• 10853366007025: ISE Mid Standard Solution for Olympus AU Series Chemistry Systems
• 10852676009774: Cal 1 for NuLyte Systems
• 10852676007053: Buffer Pack 348 for Siemens / Bayer Blood Gas Systems
• 01085267600704: Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems
• 10852676007022: Slope Solution 238 for Bayer / Ciba-Corning Blood Gas Systems
• 00852676009784: Calibrator 2 for Perlong Systems
• 00852676007216: LiquiCV STAT - Blood Gas / Electrolyte / Metabolite Linearity Control for Abbott iSTAT
• 00852676007209: LiquiCV BGM - Blood Gas / Electrolyte / Metabolite Linearity Control
• 00852676007193: LiquiCV BGP - Blood Gas / Electrolyte / Metabolite Linearity Control (Protein)
• 00852676007186: LiquiTrol ISE - Electrolyte Control - L3
• 00852676007179: LiquiTrol ISE - Electrolyte Control - L2
• 00852676007162: LiquiTrol ISE - Electrolyte Control - L1
• 00852676007155: LiquiTrol ISE - Electrolyte Control - Trilevel
• 00852676007148: LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - Trilevel
• 00852676007131: LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L3
• 00852676007124: LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L2
• 10852676007114: LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L1
• 10852676007107: LiquiCV MA - Multi-Analyte Linearity Control
• 10852676007091: LiquiTrol LP Lipid Control - L2
• 10852676007084: LiquiTrol LP Lipid Control - L1
• 00852676007070: LiquiCV EZ Enzyme Linearity Control
• 10852676007060: Wash Pack 348 for Siemens / Bayer Blood Gas Systems