TRUWAVE

Primary DI
57460691958376
Brand
TRUWAVE
Company
Edwards Lifesciences LLC
Model
T531900A
Catalog number
T531900A
Device description
PRESSURE MONITORING SET
Published
2018-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications

CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
57460691958376PackageGS120In Commercial Distribution
07460691958371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
5746069195837657460691958376
07460691958371074606919583717460691958371

GMDN Terms

TermDefinition
Invasive-pressure external transducer, single-useA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags

DUNS number
134139174
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00690103019278HEART VALVE SIZER ACCESSORY1127112723MM2026-02-11
00690103019285HEART VALVE SIZER ACCESSORY1127112725MM2026-02-11

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