VersiPD

GUDID 00840861102198

VersiPD Cycler

Fresenius Usa, Inc.

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