Cartridge Blood Set 114435

GUDID 37332414112401

The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System from Rev. SW 3.40. The Low Weight - Low Volume model is used when a low extracorporeal blood volume is recommended.

Gambro Renal Products, S.A. de C.V.

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• Primary Device ID: 37332414112401
• NIH Device Record Key: f9d5b312-8625-4bb9-8f31-bf4939ee75a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cartridge Blood Set
• Version Model Number: 114435
• Catalog Number: 114435
• Company DUNS: 812560399
• Company Name: Gambro Renal Products, S.A. de C.V.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place
• Storage Environment Temperature: Between -18 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 120 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *The blood transport system must be stored in a dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414112400 [Primary]
GS1	37332414112401 [Package]; Contains: 07332414112400; Package: CASE [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100364

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2015-10-23

On-Brand Devices [Cartridge Blood Set]

• 37332414112401: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the
• 37332414112395: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the
• 37332414085217: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the
• 37332414046836: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the
• 37332414007882: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the
• 37332414007868: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the
• 37332414007837: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the
• 37332414007813: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the