AccessGUDID - DEVICE: NON-DEHP, SINGLE DPT LINE WITH VAMP JR RESERVOIR AND LASS (07460691960572)

GUDID

Device Identifier (DI) Information

Brand Name: NON-DEHP, SINGLE DPT LINE WITH VAMP JR RESERVOIR AND LASS
Version or Model: PXVJ050M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PXVJ050M
Company Name: Edwards Lifesciences LLC

Primary DI Number: 07460691960572
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: PRESSURE MONITORING SET

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXO	Transducer, Pressure, Catheter Tip

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142749	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: a8cd2a58-1aab-46a8-b080-2da6b7703d2c
Public Version Date: July 23, 2025
Public Version Number: 1
DI Record Publish Date: July 15, 2025