Transpac 46117-22

GUDID 10887709099026

IT Transpac™ Monitoring Kit 84", 1 Disposable Transducer, 3ml Flush, Trifurcated Admin Set, Macrodrip (Pole Mount)

ICU MEDICAL, INC.

Invasive blood pressure transducer set

• Primary Device ID: 10887709099026
• NIH Device Record Key: afea6b52-ffcb-455b-9f76-762bb60cbc58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transpac
• Version Model Number: 46117-22
• Catalog Number: 46117-22
• 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: 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: true
• 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
• 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
• 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	00887709099029 [Primary]
GS1	10887709099026 [Package]; Contains: 00887709099029; Package: BOX [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: 2023-08-30
• Device Publish Date: 2023-08-22

On-Brand Devices [Transpac]

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• 10887709124582: Transpac™ IT Monitoring Kit, 66" (168 cm) Pressure Tubing, 2 way stopcocks, 3ml Flush Device a
• 10887709123967: Transpac™ IT Monitoring Kit w/Safeset™ 84" Arterial Pressure Tubing, Reservoir, 3ml Squeeze
• 10887709099026: IT Transpac™ Monitoring Kit 84", 1 Disposable Transducer, 3ml Flush, Trifurcated Admin Set, Ma