Cycler Drain Bag Set 026-20226A

GUDID 00840861102037

Fresenius Medical Care Holdings, Inc.

Extracorporeal circuit waste bag, sterile Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag Extracorporeal circuit waste bag

• Primary Device ID: 00840861102037
• NIH Device Record Key: 47336087-4f6f-48ee-b110-2edef872ab2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cycler Drain Bag Set
• Version Model Number: 026-20226A
• Catalog Number: 026-20226A
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx
• Phone: +1(800)323-5188
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing
• Special Storage Condition, Specify: Between 0 and 0 *Store at Room Temperature. Protect from excessive heat and freezing

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102037 [Primary]
GS1	10840861102034 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173363

FDA Product Code

• KDJ: Set, Administration, For Peritoneal Dialysis, Disposable

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: 2019-06-19
• Device Publish Date: 2019-06-11

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