Cycler Drain Bag Set 026-20226A

GUDID 00840861102037

Fresenius Medical Care Holdings, Inc.

Extracorporeal circuit waste bag, sterile

• 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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