VersiPD

GUDID 00840861102198

VersiPD Cycler

Fresenius Usa, Inc.

Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system Peritoneal dialysis system

• Primary Device ID: 00840861102198
• NIH Device Record Key: 05846fd9-ff7f-45da-8ec8-62f2f2344db9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersiPD
• Version Model Number: 130821
• Company DUNS: 076594100
• Company Name: Fresenius Usa, 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: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx
• Phone: 1-800-323-5188
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212522

FDA Product Code

• FKX: System, Peritoneal, Automatic Delivery

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: 2023-02-22
• Device Publish Date: 2023-02-14

On-Brand Devices [VersiPD]

• 00840861102297: VersiPD Dialysate Solution Bag Case
• 00840861102198: VersiPD Cycler
• 00840861102280: VersiPD Cart