2R1146

GUDID 50085412565946

Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar

BAXTER INTERNATIONAL INC.

Intravenous administration set

• Primary Device ID: 50085412565946
• NIH Device Record Key: 55ede469-a54e-47f9-9cd0-210028920a34
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2R1146
• Catalog Number: 2R1146
• Company DUNS: 005146311
• Company Name: BAXTER INTERNATIONAL 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: 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00085412565941 [Primary]
GS1	50085412565946 [Package]; Contains: 00085412565941; Package: CASE [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172544

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-03-29

Devices Manufactured by BAXTER INTERNATIONAL INC.

• 50085412676628 - CLR1 - CLEARLINK: 2023-07-24 Non-DEHP Solution Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 100” (2.5m) approx., 10 drops/mL
• 50085412002335 - INTERLINK: 2020-06-30 Extension Set, Injection Site, Male Luer Lock Adapter with Retractable Collar
• 50085412031199 - INTERLINK: 2020-06-30 Y-Type Blood/Solution Set, 40 and 150 Micron Dual Screen Filter, Injection Site, Male Luer Lock Adapter with Retractable Collar
• 50085412065293 - INTERLINK: 2020-06-30 Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filter and Pressure Pump, Injection Site, Male Luer Lock Adapter wi
• 50085412046162 - NA: 2020-05-06 Evacuated Container, 1000 mL
• 50085412565625 - NA: 2019-12-11 Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
• 50085412565946 - NA: 2019-12-11Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
• 50085412565946 - NA: 2019-12-11 Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
• 50085412000522 - INTERLINK/CONTINU-FLO: 2019-12-11 Non-DEHP CONTINU-FLO Solution Set, 2 Injection Sites, Male Luer Lock Adapter with Retractable Collar