Revaclear 955543A

GUDID 50085412908392

Revaclear 500 dialyzer is indicated for the treatment of chronic or acute renal failure.

Baxter Healthcare SA

Hollow-fibre haemodialysis dialyser, single-use

• Primary Device ID: 50085412908392
• NIH Device Record Key: 49defd8d-1f8f-4d81-9f23-5c453e619030
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revaclear
• Version Model Number: Revaclear 500
• Catalog Number: 955543A
• Company DUNS: 481009905
• Company Name: Baxter Healthcare SA
• 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

Device Dimensions

• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter
• Area/Surface Area: 2.1 Square meter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412908397 [Primary]
GS1	50085412908392 [Package]; Contains: 00085412908397; Package: Case [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213639

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-22
• Device Publish Date: 2024-04-12

On-Brand Devices [Revaclear]

• 50085412908439: Revaclear 300 dialyzer is indicated for the treatment of chronic or acute renal failure.
• 50085412908422: Revaclear 400 dialyzer is indicated for the treatment of chronic or acute renal failure.
• 50085412908392: Revaclear 500 dialyzer is indicated for the treatment of chronic or acute renal failure.