Transpac™ 46106-91

GUDID 10887709050911

Transpac™ IT Monitoring Kit w/3ml Flush Device and Macrodrip

ICU MEDICAL, INC.

Invasive blood pressure transducer set Invasive blood pressure transducer set Invasive blood pressure transducer set Invasive blood pressure transducer set Invasive blood pressure transducer set Invasive blood pressure transducer set Invasive blood pressure transducer set Invasive blood pressure transducer set

• Primary Device ID: 10887709050911
• NIH Device Record Key: 29c79bd4-63c0-4394-840b-b0886b57e96e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transpac™
• Version Model Number: 46106-91
• Catalog Number: 46106-91
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709050914 [Primary]
GS1	10887709050911 [Package]; Contains: 00887709050914; Package: CS [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: 2021-08-05
• Device Publish Date: 2021-07-28

On-Brand Devices [Transpac™]

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• 10887709050942: Single Line Transpac™ IT Monitoring Kit w/3ml Flush Device, Needleless Valve and 10 cc Contami
• 10887709050935: Transpac™ IT Monitoring Kit w/3 Way Stopcock and 48" Pressure Tubing
• 10887709049649: 4 Port "OFF" Manifold w/HP Stopcock, Waste Bag Assy, 10cc Syringe, TP IT and AD Set
• 10887709049120: Adult Right Heart Kit w/TP IT
• 10887709049113: Cath Lab Kit W/5 Port "OFF" Manifold & TP IT
• 10887709049106: Left Heart Adult Kit w/Transpac™ IT
• 10887709048758: Neonatal Monitoring Kit w/Transpac™ IT and 30ml Flush Device
• 10887709048659: Cath Lab Kit Transpac™ IT w/3ml Flush Device
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• 10887709047157: Cardiac Catheterization Left Heart Kit With Waste System, HP Tubing, Syringe & TP IT
• 10887709046327: Cath Lab Kit, TP IT
• 10840619069053: 2 Port Right "Off" Manifold w/ Admin Set, 72" PT, 3 Way Stopcock, TP IT & 1 Way Stopcock
• 10840619069039: Cath Lab Kit w/Transpac™ IT
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• 10840619063259: Cath Lab Kit w/Waste Bag, dyePod®, Sosa Spike & Syringe
• 10840619061514: Cardiac Cath Lab w/Transpac™ IT
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• 10840619045422: 3 Port "OFF" Manifold, 20" HP PT w/Rotator, Bonded TP IT, 48" HP PT w/Male 12cc Syringe w/Rotato
• 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
• 10887709087450: Transpac™ IT Monitoring Kit w/Safeset™ 60" Arterial Pressure Tubing, Reservoir, 3ml Flush De
• 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
• 10887709075341: Transpac™ IT Kit w/03 ml Squeeze Flush Device, PT Tubings, 3 3-Way Stopcocks and 36" Admin Set
• 10887709073613: Transpac™ IT Monitoring Kit w/ Safeset™ Reservoir and Blood Sampling Port, 3ml Flush Device,
• 10887709071183: Transpac™ IT Monitoring Kit w/84" Safeset™ Reservoir, Red Stripe TBG, 3ml Flush Device and N
• 10887709067650: Transpac™ IT Kit w/2 3-Way Stopcocks and 48" Pressure TBG
• 10887709064482: Transpac™ IT Monitoring Kit w/3ml Flush Device, 36" Smallbore Tubing and 3 Way Stopcock
• 10887709062068: Transpac™ IT Monitoring Kit w/3ml Flush Device, Arterial Safeset™ Reservoir and Needleless V
• 10887709061825: Transpac™ IT Monitoring Kit w/Arterial 84" Safeset™ Reservoir, 3ml Flush Device and Needlele
• 10887709061795: Transpac™ IT Monitoring Kit w/3ml Flush Device, 3 3 Way Stopcocks and 2 6" PT Tubings
• 10887709061788: Transpac™ IT Monitoring Kit, 60", 3ml Flush Device, 2 3 Way Stopcocks and Macrodrip
• 10887709061771: Transpac™ IT Monitoring Kit, 12", 3ml Flush Device, 2 3 Way Stopcocks and Macrodrip
• 10887709060569: Transpac™ IT Monitoring Kit w/Safeset™ 72" Pressure Tubing, Reservoir, 3ml Flush and 2 Needl
• 10887709052595: Spike Set w/Transpac™ IT, 3ml Flush Device, Safeset™ Blood Sampling Port and 10ml Sheathed S
• 10887709050911: Transpac™ IT Monitoring Kit w/3ml Flush Device and Macrodrip
• 10887709050904: Transpac™ IT Monitoring Kit w/Safeset™ 84" PT Blue Stripe Tubing, Reservoir, 3ml Flush and N
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