POLYFLUX REVACLEAR MAX 110634

GUDID 37332414101702

Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis

GAMBRO RENAL PRODUCTS, INC.

Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use Hollow-fibre haemodialysis dialyser, single-use

• Primary Device ID: 37332414101702
• NIH Device Record Key: 4f1ca14a-b06c-4d10-9c7e-528e3af526e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: POLYFLUX REVACLEAR MAX
• Version Model Number: 110634
• Catalog Number: 110634
• Company DUNS: 929768682
• Company Name: GAMBRO RENAL PRODUCTS, 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: 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
• 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

• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414101701 [Primary]
GS1	37332414101702 [Package]; Contains: 07332414101701; Package: CASE [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060195

FDA Product Code

• KDI: Dialyzer, high permeability with or without sealed dialysate system

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: 2019-05-30
• Device Publish Date: 2015-10-07

Devices Manufactured by GAMBRO RENAL PRODUCTS, INC.

• 37332414101696 - POLYFLUX REVACLEAR: 2019-05-30 Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
• 37332414101702 - POLYFLUX REVACLEAR MAX: 2019-05-30Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
• 37332414101702 - POLYFLUX REVACLEAR MAX: 2019-05-30 Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis
• 37332414123056 - REVACLEAR: 2018-07-06 Revaclear 300 and 400 dialyzers are indicated for the treatment of chronic and acute renal failure by hemodialysis
• 37332414124077 - REVACLEAR: 2018-07-06 Revaclear 400 dialyzer is indicated for treatment of chronic and acute renal failure by hemodialysis