Transpac™ 460680465

GUDID 10887709046761

Neonatal Kit Transpac™ IT w/30ml Flush Device (Only for Use with Infusion Pump)

ICU MEDICAL, INC.

In-line arterial blood sampling set

• Primary Device ID: 10887709046761
• NIH Device Record Key: 5ecc5216-1354-4954-9828-50d55e420a86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transpac™
• Version Model Number: 460680465
• Catalog Number: 460680465
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887709046764 [Primary]
GS1	10887709046761 [Package]; Contains: 00887709046764; 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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-08-27
• Device Publish Date: 2021-07-27

On-Brand Devices [Transpac™]

• 10887709086132: Monitoring Kit w/Transpac™ IT, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Nee
• 10887709075358: Transpac™ IT Trifurcated Kit w/3ml Flush Device, PT Tubings, 3 3-Way Stopcocks and Admin Set
• 10887709066745: Cath Lab Kit w/3 Port, Right "ON" Manifold (600 psi), Transpac™ IT, 8 cc Control Syringe
• 10887709066523: Cath Lab Kit w/3 Port "ON" Manifold (600 psi), Transpac™ IT, 2 Admin Sets and 8 cc Control Syr
• 10887709061764: Transpac™ IT Monitoring Kit, 48", 3ml Flush Device and Macrodrip
• 10887709061757: Neonatal Arterial Transpac™ IT Kit w/30 ml Squeeze Flush Device
• 10887709059921: Cath Lab Kit w/TP IT
• 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
• 10887709048291: Cath Lab Kit Transpac™ IT w/30ml Flush Device
• 10887709048260: Cath Lab Kit w/Transpac™ IT Flush Device
• 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
• 10840619063730: Cath Lab kit w/03 ml Intraflo,2 Port Manifold Right OFF Rotator and TP IT
• 10840619063259: Cath Lab Kit w/Waste Bag, dyePod®, Sosa Spike & Syringe
• 10840619061514: Cardiac Cath Lab w/Transpac™ IT
• 10840619061002: Cath Lab Kit /Transpac™ IT and 3ml Flush Device
• 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
• 10887709050898: Transpac™ IT Kit w/Bonded Double Female Luer