CombiSet 03-2522-1

GUDID 10840861102409

Fresenius Medical Care Holdings, Inc.

Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use Haemodialysis blood tubing set, single-use

• Primary Device ID: 10840861102409
• NIH Device Record Key: ad74aef8-6d08-4144-9dce-2d759844dff1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CombiSet
• Version Model Number: 03-2522-1
• Catalog Number: 03-2522-1
• 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: false
• Manufacturing Date: false
• 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: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx
• Phone: 800-323-5188
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat
• Special Storage Condition, Specify: Between 0 and 0 *Protect from moisture, freezing, and excessive heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102402 [Primary]
GS1	10840861102409 [Package]; Contains: 00840861102402; Package: [28 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213992

FDA Product Code

• FJK: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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: 2023-10-27
• Device Publish Date: 2023-10-19

On-Brand Devices [CombiSet]

• 10840861100474: Pre-pump, 8.0 mm, BVM
• 10840861100337: Pre-pump, 8.0 mm, Home Hemo with prime bag
• 10840861100320: Pre-pump, 8.0 mm
• 10840861100306: Pre-pump, 8.0 mm
• 10840861100290: Pre-pump, 8.0 mm
• 10840861100283: 8.0 mm, single needle
• 10840861100269: Pre-pump, 6.35 mm, low volume
• 10840861100252: Post-pump, 6.35 mm
• 10840861100245: Pre-pump, 6.35 mm
• 10840861100238: Pre-pump, 8.0 mm
• 10840861100221: Post-pump, 8.0 mm
• 10840861102409: 03-2522-1