Easy-Lock 5C4136

GUDID 50085412050824

This adapter consists of a spike connector, approx. 10.15 cm (4") long, 3.81 mm (0.150") ID tubing and a flanged Easy-Lock Connector. This device is indicated for the personal cycler peritoneal dialysis system used for automatic control of dialysate solution exchanges in the treatment of renal failure patients undergoing peritoneal dialysis.

BAXTER HEALTHCARE CORPORATION

Peritoneal dialysis system tubing set

• Primary Device ID: 50085412050824
• NIH Device Record Key: 4144d8ee-71b5-471d-b365-be4eccda5158
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy-Lock
• Version Model Number: 5C4136
• Catalog Number: 5C4136
• Company DUNS: 005083209
• Company Name: BAXTER HEALTHCARE CORPORATION
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not exceed 40 degrees Celcius, 104 degrees Farenheit. Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Do not exceed 40 degrees Celcius, 104 degrees Farenheit. Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Do not exceed 40 degrees Celcius, 104 degrees Farenheit. Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Do not exceed 40 degrees Celcius, 104 degrees Farenheit. Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Do not exceed 40 degrees Celcius, 104 degrees Farenheit. Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Do not exceed 40 degrees Celcius, 104 degrees Farenheit. Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Do not exceed 40 degrees Celcius, 104 degrees Farenheit. Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Do not exceed 40 degrees Celcius, 104 degrees Farenheit. Store at room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Do not exceed 40 degrees Celcius, 104 degrees Farenheit. Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412050829 [Primary]
GS1	50085412050824 [Package]; Contains: 00085412050829; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923065

FDA Product Code

• FKX: System, peritoneal, automatic delivery

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: 2018-12-17
• Device Publish Date: 2018-11-14

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