Transpac 47100-02

GUDID 10887709123967

Transpac™ IT Monitoring Kit w/Safeset™ 84" Arterial Pressure Tubing, Reservoir, 3ml Squeeze Flush and 2 Needleless Valves

ICU MEDICAL, INC.

Invasive blood pressure transducer set

• Primary Device ID: 10887709123967
• NIH Device Record Key: 1cd15d1b-7541-479f-a8c6-792a111c4898
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transpac
• Version Model Number: 47100-02
• Catalog Number: 47100-02
• 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
• 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	00887709123960 [Primary]
GS1	10887709123967 [Package]; Contains: 00887709123960; Package: Case [20 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: 2021-11-29
• Device Publish Date: 2021-11-20

On-Brand Devices [Transpac]

• 10840619033559: Transpac® IV Monitoring Kit, 60", Disposable Transducer, 3 ML Intraflo® Flush, Macrodrip (Pole
• 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