stay•safe® Handi-tool

GUDID 10840861102324

Fresenius Medical Care Holdings, Inc.

Assistive gripping/twisting disc, single-use

• Primary Device ID: 10840861102324
• NIH Device Record Key: bc3fd3e6-4be0-440c-842c-c95d13c4df10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: stay•safe® Handi-tool
• Version Model Number: 030-10810-1
• 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: 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: 1-800-323-5188
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840861102327 [Primary]
GS1	10840861102324 [Package]; Contains: 00840861102327; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173718

FDA Product Code

• FKX: System, Peritoneal, Automatic Delivery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-21
• Device Publish Date: 2019-05-09

Devices Manufactured by Fresenius Medical Care Holdings, Inc.

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• 10840861102669 - FX CorAL 120 Dialyzer: 2024-03-04
• 10840861102676 - FX CorAL 600 Dialyzer: 2024-03-04
• 10840861102683 - FX CorAL 800 Dialyzer: 2024-03-04
• 10840861102690 - FX CorAL 1000 Dialyzer: 2024-03-04
• 10840861102409 - CombiSet: 2023-10-27