NON-DEHP, SINGLE DPT LINE WITH VAMP JR RESERVOIR AND LASS

Basic Information

• Brand Name: NON-DEHP, SINGLE DPT LINE WITH VAMP JR RESERVOIR AND LASS
• Primary DI: 07460691960572
• Version / Model: PXVJ050M
• Catalog Number: PXVJ050M
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-15
• Public Version: 1
• Public Version Date: 2025-07-23
• Public Version Status: New
• Public Device Record Key: a8cd2a58-1aab-46a8-b080-2da6b7703d2c

Device Description

PRESSURE MONITORING SET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
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
Primary	07460691960572	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142749	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Volume 3 cc, Length 30 cm