DEVICE: TRUWAVE (07460691952317)

Download: XML | JSON

Device Identifier (DI) Information

TRUWAVE
55UF100
55UF100
Edwards Lifesciences LLC
07460691952317
GS1
1
PRESSURE MONITORING ACCESSORY
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Pressure transducer dome, single-use A sterile plastic housing that connects together with the pressure transducer, forming a measuring compartment. The transducer is influenced by the pressure of the medium, e.g., blood directly from a patient, that is channelled into the compartment, thereby creating the signals. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DXO TRANSDUCER, PRESSURE, CATHETER TIP
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: RATE: 3 MILLILITER/HOUR
CLOSE

Device Status

In Commercial Distribution
September 03, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
57460691952312 20 07460691952317 In Commercial Distribution Shipper
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(800)822-9637
tech_support@edwards.com
CLOSE