CO-SET+ 93600

GUDID 07460691949997

CO-SET DELIVERY SYSTEM FOR COLD INJECTATE

Edwards Lifesciences LLC

Thermal-dilution cardiac output unit
Primary Device ID07460691949997
NIH Device Record Keydfcbcde4-0a3d-42ee-bcde-2b53890fd583
Commercial Distribution StatusIn Commercial Distribution
Brand NameCO-SET+
Version Model Number93600
Catalog Number93600
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 Datefalse
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 Volume10 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107460691949997 [Primary]
GS157460691949992 [Package]
Package: Shipper [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRBPROBE, THERMODILUTION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-03

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00690103004250INJECTATE TEMPERATURE PROBE
00690103003260CO-SET INJECTATE PROBE CABLE
07460691955448CO - SET MOD ROOM TEMPERATURE STERILE
07460691950023CO-SET+ (DUAL STOPCOCKS) CLOSED INJECTATE DELIVERY SYS
07460691950016CO-SET(R) AND SYRINGE F/USE W/ 93-500,-510,-600,-610 5EA/CA
07460691950009CO-SET DELIVERY SYSTEM FOR 123 ROOM TEMPATURE INJECTATE
07460691949997CO-SET DELIVERY SYSTEM FOR COLD INJECTATE
07460691949973CO-SET HOUSING CASE OF 8
00690103197143PROBE,TEMP F/MARQUETTE N/S PART NUMBER 650405005

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