EPOC BGEM TEST CARD

GUDID 00809708047283

Epocal Inc

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

• Primary Device ID: 00809708047283
• NIH Device Record Key: d5dc330e-6b1b-42b4-a54f-38ea2546a2d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPOC BGEM TEST CARD
• Version Model Number: CT-1004-00-00
• Company DUNS: 201179681
• Company Name: Epocal 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: true
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: XX@XX.XX
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00809708047283 [Primary]

FDA Product Code

• CEM: Electrode, Ion Specific, Potassium

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-17

Devices Manufactured by Epocal Inc

• 00630414606095 - epoc NXS Host: 2020-07-24 The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequa
• 00630414606460 - epoc Host2: 2020-07-23 The epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for thequa
• 00809708041137 - CAPILLARY TUBE, CARE-FILL, BUNDLE OF 50: 2018-08-09
• 00809708049232 - TUBE, CAPILLARY, VETERINARY, (BUNDLE 50): 2018-08-09
• 00809708114572 - EDM LITE KIT: 2018-05-18
• 00809708121860 - EPOC BGEM BUN TEST CARD: 2018-05-18
• 00809708150303 - EPOC HOST 2, VETERINARY, CHINA: 2018-05-18
• 00809708150310 - EPOC HOST 2, VETERINARY, CHINA, REFURBISHED: 2018-05-18