Centrisol Acid Concentrate

GUDID 30677964000523

MEDIVATORS INC.

Haemodialysis concentrate

• Primary Device ID: 30677964000523
• NIH Device Record Key: cd9de1c1-a1bc-4e82-a403-f1add41802b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Centrisol Acid Concentrate
• Version Model Number: SB-129
• Company DUNS: 068199363
• Company Name: MEDIVATORS 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: 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: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com
• Phone: +1(800)444-4729
• Email: custserv@MEDIVATORS.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964000522 [Primary]
GS1	30677964000523 [Package]; Contains: 00677964000522; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K843963

FDA Product Code

• FKQ: System, Dialysate Delivery, Central Multiple Patient

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: 2016-09-20

On-Brand Devices [Centrisol Acid Concentrate]

• 30677964091767: SB-353
• 00677964082214: SB-353
• 00677964056468: SB-164
• 30677964056452: SB-164
• 30677964044367: SB-330
• 00677964044359: SB-342
• 30677964044343: SB-342
• 00677964044335: SB-343
• 00677964044328: SB-344
• 30677964044312: SB-344
• 00677964044304: SB-351
• 30677964044299: SB-351
• 00677964044281: SB-352
• 30677964044275: SB-352
• 00677964006012: SB-152
• 00677964005855: SB-144
• 00677964005794: SB-143
• 00677964005732: SB-142
• 00677964005527: SB-127
• 00677964005367: SB-111
• 30677964000615: SB-152
• 30677964000608: SB-151
• 30677964000592: SB-145
• 30677964000585: SB-144
• 30677964000578: SB-143
• 30677964000561: SB-142
• 30677964000554: SB-140
• 30677964000547: SB-137
• 30677964000530: SB-130
• 30677964000523: SB-129
• 30677964000516: SB-127
• 30677964000509: SB-123
• 30677964000493: SB-119
• 30677964000486: SB-111