Diasafe 5008203

GUDID 04039361001391

FILTER, DIASAFE PLUS

Fresenius Medical Care AG & Co. KGaA

Haemodialysis system dialysate pyrogen filter

• Primary Device ID: 04039361001391
• NIH Device Record Key: 72fc770e-4a9f-4dec-8c14-4ba17a1c761d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diasafe
• Version Model Number: 5008201
• Catalog Number: 5008203
• Company DUNS: 324661834
• Company Name: Fresenius Medical Care AG & Co. KGaA
• 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: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx
• Phone: +1(800)227-2572
• Email: xxx@xxx.xxx

Device Dimensions

• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter
• Area/Surface Area: 2.2 Square meter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04039361001384 [Primary]
GS1	04039361001391 [Package]; Contains: 04039361001384; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944767

FDA Product Code

• FIP: SUBSYSTEM, WATER PURIFICATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-30
• Device Publish Date: 2015-10-23

Devices Manufactured by Fresenius Medical Care AG & Co. KGaA

• 04039361001117 - Hemoflow™: 2024-06-12 F40S Hemoflow Dialyzer / High Flux / Polysulfone / 0.7 m2 / Steam / Single Use / 42 mL
• 04039361001391 - Diasafe: 2020-03-30FILTER, DIASAFE PLUS
• 04039361001391 - Diasafe: 2020-03-30 FILTER, DIASAFE PLUS