VersiPD

GUDID 10840861102614

VersiPD Line Holder Nest with Anchors

Fresenius Medical Care Holdings, 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: 10840861102614
• NIH Device Record Key: e9cf6300-75cb-487e-9232-c610bb4c0450
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersiPD
• Version Model Number: 030-40000
• 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: 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: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• Email: xx@xx.xx
• Phone: 1-800323-5188
• 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	00840861102617 [Primary]
GS1	10840861102614 [Package]; Contains: 00840861102617; Package: Case [52 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: 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]

• 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