Alaris, Signature Edition 11258586

GUDID 50885403422247

SE SYR DEHP-FREE

CAREFUSION 303, INC.

Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use

• Primary Device ID: 50885403422247
• NIH Device Record Key: 7cc0e800-213b-4dcb-a421-cda69d8c6e9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alaris, Signature Edition
• Version Model Number: 11258586
• Catalog Number: 11258586
• Company DUNS: 360624720
• Company Name: CAREFUSION 303, INC.
• Device Count: 50
• 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)854-7128
• Email: CustCareInfusion@carefusion.com
• Phone: +1(800)854-7128
• Email: CustCareInfusion@carefusion.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403422249 [Unit of Use]
GS1	50885403422247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934095

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: 4
• Public Version Date: 2020-04-27
• Device Publish Date: 2017-07-27

On-Brand Devices [Alaris, Signature Edition]

• 50885403463394: SE VTD LOW SORB
• 50885403422247: SE SYR DEHP-FREE
• 50885403422209: SE 20DP 1.2 FLTR SET
• 50885403422162: Alaris Signature Edition Infusion Set
• 50885403422063: SE LOW DUROMETER CKV 3 SS 10DP 50PK
• 50885403422049: Alaris SE Pump Enteral Set
• 50885403422025: Alaris Signature Edition Infusion Burette Set
• 50885403422018: SE W/150 BURETTE MIC 3VLV PO
• 50885403421974: Alaris Signature Edition Infusion Set
• 50885403421967: SE PRIMARY SET 2 VS PORTS
• 50885403421950: SE STANDARD 2 YS
• 50885403275348: Alaris SE Pump Infusion Set
• 50885403275188: Alaris SE Pump Infusion Set
• 50885403275164: SE PRI SET 20DP 2SS W/MIC TBG
• 50885403275157: Alaris SE Pump Infusion Set
• 50885403275119: Alaris SE Pump Module Infusion Set
• 50885403275096: Alaris SE Pump Blood Infusion Set
• 50885403275089: Alaris SE Pump Blood Infusion Set
• 50885403206304: Alaris Signature Edition Burette Infusion Set
• 37613203010369: Alaris SE Pump Infusion Set
• 37613203009929: Alaris SE Pump Infusion Set
• 37613203009844: Alaris SE Pump Low Sorbing Infusion Set
• 37613203009806: Alaris SE Pump Infusion Set
• 37613203009721: Alaris SE Pump Syringe Adapter Set