PRESSURE MONITORING SET T530116B

GUDID 57460691938965

TRUWAVE

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use
Primary Device ID57460691938965
NIH Device Record Key3e3cd092-467e-414b-aae2-aa4cd3d0f814
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRESSURE MONITORING SET
Version Model NumberT530116B
Catalog NumberT530116B
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9637
Emailtech_support@edwards.com

Device Dimensions

Total Volume3 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS107460691938960 [Primary]
GS157460691938965 [Package]
Contains: 07460691938960
Package: SHIPPER [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXOTransducer, Pressure, Catheter Tip

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-07
Device Publish Date2018-08-07

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