AccessGUDID - DEVICE: TRUWAVE X 2 (3CC) / VAMP JR 54 IN (136 CM) (07460691930179)

GUDID

Device Identifier (DI) Information

Brand Name: TRUWAVE X 2 (3CC) / VAMP JR 54 IN (136 CM)
Version or Model: T443952B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T443952B
Company Name: Edwards Lifesciences LLC

Primary DI Number: 07460691930179
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:	No
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

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 CC, LENGTH: 54 INCH (136 CENTIMETER)

Device Record Status

Public Device Record Key: c23d1b56-2807-474d-90e2-1434ac3ecc38
Public Version Date: September 13, 2024
Public Version Number: 1
DI Record Publish Date: September 05, 2024