MARS TREATMENT KIT TYPE 1116/1 - X-MARS US 800541

GUDID 37332414107728

The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device

GAMBRO AB

Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set Bound solute dialysis system component set

• Primary Device ID: 37332414107728
• NIH Device Record Key: e1a492a7-ec05-46d4-8bd0-edd1f9f54f59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MARS TREATMENT KIT TYPE 1116/1 - X-MARS US
• Version Model Number: 800541
• Catalog Number: 800541
• Company DUNS: 354021099
• Company Name: GAMBRO AB
• 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: true
• 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
• 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 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 39.2 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	37332414107728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133807

FDA Product Code

• FLD: Apparatus, Hemoperfusion, Sorbent

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: 2019-02-13
• Device Publish Date: 2017-10-26

Devices Manufactured by GAMBRO AB

• 37332414127214 - CLCA - CLEANCART A: 2023-12-11 CleanCart A
• 37332414127221 - CLCC - CLEANCART C: 2023-12-11 CleanCart C
• 07332414124519 - AK 98: 2021-03-30 Intended for intermittant haemodialysis and/or isolated ultrafiltration treatments. Indicated to be used on patients with a body
• 07332414126766 - PRISMAFLEX: 2019-03-11 The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy an
• 37332414107728 - MARS TREATMENT KIT TYPE 1116/1 - X-MARS US: 2019-02-13The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with the Prismaflex device
• 37332414107728 - MARS TREATMENT KIT TYPE 1116/1 - X-MARS US: 2019-02-13 The MARS Treatment Kit Type 1116/1 X-MARS is a set of disposable items to be used with the MARS Monitor 1TC in combination with
• 37332414106950 - Mars Treatment Kit: 2018-07-06 The MARS Treatment Kit type 1115/1-PrisMARS US is a set of disposable items to be used with the MARS Monitor 1TC for performing
• 37332414088317 - BiCart: 2018-07-06 Sodium Bicarbonate for Hemodialysis
• 07332414105266 - Prismaflex: 2018-07-06 The Prismaflex control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy an