Transpac™ 46114-32

GUDID 10887709075358

Transpac™ IT Trifurcated Kit w/3ml Flush Device, PT Tubings, 3 3-Way Stopcocks and Admin Set

ICU MEDICAL, INC.

Invasive blood pressure transducer set

• Primary Device ID: 10887709075358
• NIH Device Record Key: a1255f3a-7301-4556-bbce-76fd24e281bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transpac™
• Version Model Number: 46114-32
• Catalog Number: 46114-32
• Company DUNS: 118380146
• Company Name: ICU MEDICAL, 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: true
• 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(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com
• Phone: +1(866)829-9025
• Email: customerservice@icumed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709075351 [Primary]
GS1	10887709075358 [Package]; Contains: 00887709075351; Package: CS [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052828

FDA Product Code

• DRS: Transducer, blood-pressure, extravascular

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: 2021-08-04
• Device Publish Date: 2021-07-27

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