AccessGUDID - DEVICE: TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM) (07460691949287)

GUDID

Device Identifier (DI) Information

Brand Name: TRUWAVE X 2 (3 CC) /VAMP 78 IN (200 CM)
Version or Model: T005049B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T005049B
Company Name: Edwards Lifesciences LLC

Primary DI Number: 07460691949287
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?
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
DXO	Transducer, Pressure, Catheter Tip

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183413	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
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: TOTAL VOLUME: 3 Milliliter, LENGTH: 78 INCH (200 CENTIMETER)

Device Record Status

Public Device Record Key: 77e7d0ad-20a6-4e06-881e-481bff7c3f9b
Public Version Date: September 12, 2024
Public Version Number: 1
DI Record Publish Date: September 04, 2024