FiberFlo M-I-EN-A

GUDID 00677964032639

MEDIVATORS INC.

Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter Particulate water purification filter

• Primary Device ID: 00677964032639
• NIH Device Record Key: 59fba7cf-2b87-420b-9414-44105fe22ce7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FiberFlo
• Version Model Number: 93250-148
• Catalog Number: M-I-EN-A
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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	00677964032639 [Primary]
GS1	30677964032630 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983126

FDA Product Code

• FIP: Subsystem, Water Purification

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: 2018-07-13
• Device Publish Date: 2018-06-12

On-Brand Devices [FiberFlo]

• 00677964053566: 93250-205
• 00677964052514: 93250-204
• 00677964044236: 93250-194
• 00677964042560: 93250-192
• 00677964042553: 93250-191
• 00677964042546: 93250-190
• 00677964042478: 93250-182
• 00677964042454: 93250-180
• 00677964042423: 93250-177
• 00677964042416: 93250-179
• 00677964042393: 93250-174
• 00677964042102: 93023-255
• 00677964032721: 93250-157
• 00677964032653: 93250-150
• 00677964032639: 93250-148
• 00677964032585: 93250-143
• 00677964032578: 93250-142
• 00677964032424: 93250-127
• 00677964032363: 93250-121
• 00677964032301: 93250-115
• 00677964032295: 93250-114
• 00677964032141: 93250-099
• 00677964032134: 93250-098
• 00677964032127: 93250-097
• 30677964032081: 93250-093
• 00677964031823: 93250-070
• 00677964031502: 93250-034
• 00677964031472: 93250-032
• 00677964031458: 93250-030
• 00677964031441: 93250-029
• 00677964031434: 93250-028
• 00677964031410: 93250-026
• 00677964031403: 93250-025
• 00677964031397: 93250-024
• 00677964031250: 93250-010
• 00677964031243: 93250-009
• 00677964031236: 93250-008
• 00677964031212: 93250-002
• 00677964031205: 93250-001
• 00677964031199: 93250-000
• 00677964030345: 93023-236
• 00677964029509: 93023-152
• 00677964029493: 93023-151
• 00677964029486: 93023-150
• 00677964029479: 93023-149
• 00677964029462: 93023-148
• 00677964029455: 93023-147
• 00677964029448: 93023-146
• 00677964029431: 93023-145
• 00677964029424: 93023-144