Combo Kit

Basic Information

• Brand Name: Combo Kit
• Primary DI: 00690103200317
• Version / Model: PXVMPL172
• Catalog Number: PXVMPL172
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-17
• Public Version: 1
• Public Version Date: 2019-04-25
• Public Version Status: New
• Public Device Record Key: 73f0670e-c685-4c0d-ae4c-e43def6d4e06

Device Description

Pressure Monitoring Set

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	870.2870	2
KRA	Catheter, Continuous Flush	Cardiovascular	870.1210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35927	Invasive-pressure external transducer, single-use	A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.	No	Active
31336	Arterial blood sampling kit	A collection of sterile devices intended to obtain an arterial blood specimen directly from a patient, usually for the determination of blood gas concentration. It typically includes a needle, heparinized syringe, sterile gauze/swab, bandage, rubber band, stopper, and patient identification label. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50690103200312	GS1	Shipper	10	In Commercial Distribution
Primary	00690103200317	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141495	000
K142749	000
K161962	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Length 65 inches, volume 3 cc

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool dry place