Transpac™ 46300-02

GUDID 10887709066745

Cath Lab Kit w/3 Port, Right "ON" Manifold (600 psi), Transpac™ IT, 8 cc Control Syringe

ICU MEDICAL, INC.

Angiography kit

• Primary Device ID: 10887709066745
• NIH Device Record Key: 35791f5a-d7dd-47c4-b217-eddc62403ae7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transpac™
• Version Model Number: 46300-02
• Catalog Number: 46300-02
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709066748 [Primary]
GS1	10887709066745 [Package]; Contains: 00887709066748; Package: CS [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932141

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

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

On-Brand Devices [Transpac™]

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• 10840619045217: Cardiac Catheterization Right Heart Kit With 2-Station Right Hand, On, High Pressure Manifold An
• 10840619040878: Cardiac Catheterization Basic Kit With Transpac™ IT and 3-Station, Right, ON, High Pressure Ma
• 10887709089898: Transpac™ IT Kit w/Stopcocks and 18" PT Tubing
• 10887709089041: Transpac™ IT Monitoring Kit w/03 ml Squeeze Flush, Pressure Tubing, 3 Way Stopcocks, Red Plugs
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• 10887709087405: Arterial Set-Up w/3ml Flush Device, Transpac™ IT, Admin Un-Bonded
• 10887709082493: Transpac™IT Monitoring Kit w/3ml Flush Device, Needleless Valve, 10 cc Contamination Sheath Sy
• 10887709081496: Transpac™ IT Kit w/2 3-Way Stopcocks and 48" Pressure TBG
• 10887709081199: Transpac™ IT Trifurcated Monitoring Kit w/3ml Flush Device, PT Tubings, 3-Way Stopcocks and Ad
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