T005086A T005086A

GUDID 57460691956075

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use
Primary Device ID57460691956075
NIH Device Record Keycfa0a823-2163-4d37-a111-0919ea6e55b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameT005086A
Version Model NumberT005086A
Catalog NumberT005086A
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

Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107460691956070 [Primary]
GS157460691956075 [Package]
Contains: 07460691956070
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 Date2018-08-27
Device Publish Date2018-07-25

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