VersiPD

GUDID 10840861102218

Disposable Set - 20 ft patient line, 20 ft drain line, 3 solution lines, 1 stay-safe PIN connector

Fresenius Medical Care Holdings, Inc.

Peritoneal dialysis system tubing set

• Primary Device ID: 10840861102218
• NIH Device Record Key: a5630695-2a33-4994-b668-b401a20ed9b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersiPD
• Version Model Number: 050-87225
• Company DUNS: 958291411
• Company Name: Fresenius Medical Care Holdings, 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102211 [Primary]
GS1	10840861102218 [Package]; Contains: 00840861102211; Package: Box [10 Units]; In Commercial Distribution

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: true

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]

• 10840861102614: VersiPD Line Holder Nest with Anchors
• 10840861102232: Disposable Set - 20 ft patient line, 20 ft drain line, 4 solution lines, 2 stay-safe PIN connect
• 10840861102225: Disposable Set - 10 ft patient line, 4 ft drain line, 3 solution lines, 1 stay-safe PIN connecto
• 10840861102218: Disposable Set - 20 ft patient line, 20 ft drain line, 3 solution lines, 1 stay-safe PIN connect