AccessGUDID - DEVICE: TRUWAVE(3 CC)/ VAMP PLUS 86 IN (218 CM) (00690103197686)

GUDID

Device Identifier (DI) Information

Brand Name: TRUWAVE(3 CC)/ VAMP PLUS 86 IN (218 CM)
Version or Model: PXVPL0029
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PXVPL0029
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103197686
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:	Yes
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
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRA	Catheter, Continuous Flush
DXO	Transducer, Pressure, Catheter Tip

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141495	000
K142749	000
K161962	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Total Volume: 3 cc, Length: 86 Inch (218 Centimeter)

Device Record Status

Public Device Record Key: c8277b29-28c2-4efd-bffb-5373c4b95d68
Public Version Date: August 08, 2019
Public Version Number: 4
DI Record Publish Date: May 30, 2019