FLOTRAC, TRUWAVE MHD8C503

GUDID 00690103194753

FLOTRAC SENSOR

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use
Primary Device ID00690103194753
NIH Device Record Key5e622ba8-b7d4-4287-aba7-3bb2d69604bb
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLOTRAC, TRUWAVE
Version Model NumberMHD8C503
Catalog NumberMHD8C503
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
Phone+1(800)822-9637
Emailtech_support@edwards.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE.
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103194753 [Primary]
GS150690103194758 [Package]
Package: Shipper [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXGCOMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-03

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