CER-1

GUDID 00677964021695

MEDIVATORS INC.

Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer/disinfector Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical) Endoscope washer-disinfector (chemical)

• Primary Device ID: 00677964021695
• NIH Device Record Key: 986fa5e8-fe14-4d8d-b9a0-e9581ab02253
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CER-1
• Version Model Number: CER-1
• 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: false
• Serial Number: true
• 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)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com
• Phone: +1(800)548-4873
• Email: custserv@medivators.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00677964021695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K871712

FDA Product Code

• NVE: Washer, Cleaner, Automated, Endoscope

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

Devices Manufactured by MEDIVATORS INC.

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• 40677964048997 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Flat Sponge, Defendo Fuji 5-piece Valves Kit, Absorbent Pad, Lu
• 40677964049147 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Cylindrical Sponge, 5-piece Olympus DCA Kit, Absorbent Pad, Lub
• 40677964049161 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Cylindrical Sponge, Defendo Pentax 4-piece Valves Kit, Absorben
• 40677964049253 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, 4-piece Olympus DCA Kit, Transport Pad and Lubricant.
• 40677964049277 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Enzymatic Sponge, Transport Pad, Lubricant, Gauze, Gown and Biohazard Sticker.
• 40677964049291 - Endo Carry-on Procedure Kit: 2024-07-09 Endo Carry-on Procedure Kit Includes Basin, Intercept Detergent, Flat Sponge, Defendo 4-piece Valves Kit, Drawstring Transport P