pH Electrode 6201

GUDID 00386100002305

pH electrode for use with EasyBloodGas and EasyStat analyzers

MEDICA CORPORATION

Blood gas pH IVD, kit, ion-selective electrode (ISE)

• Primary Device ID: 00386100002305
• NIH Device Record Key: 8849640f-efcb-4a08-bc7b-4a63b2d12d91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pH Electrode
• Version Model Number: 6201
• Catalog Number: 6201
• Company DUNS: 112942404
• Company Name: MEDICA 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: 781-275-4892
• Email: technicalsupport@medicacorp.com
• Phone: 781-275-4892
• Email: technicalsupport@medicacorp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386100002305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974526

FDA Product Code

• CHL: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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: 2019-01-07
• Device Publish Date: 2018-12-05

On-Brand Devices [pH Electrode]

• 00386100003142: ISE pH electrode for use with EasyLyte Analyzers
• 00386100002305: pH electrode for use with EasyBloodGas and EasyStat analyzers