CO-SET INJECTATE ICE BUCKET 93520

GUDID 50690103000073

CO-SET INJECTATE ICE BUCKET 6 PER CASE

Edwards Lifesciences LLC

General-purpose patient temperature probe, reusable
Primary Device ID50690103000073
NIH Device Record Keye1a9ff25-6994-4883-9487-c2339afc1b73
Commercial Distribution StatusIn Commercial Distribution
Brand NameCO-SET INJECTATE ICE BUCKET
Version Model Number93520
Catalog Number93520
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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.
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.
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.
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.
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.
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
GS100690103000078 [Primary]
GS150690103000073 [Package]
Contains: 00690103000078
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRBProbe, Thermodilution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-24
Device Publish Date2025-07-16

Devices Manufactured by Edwards Lifesciences LLC

57460691952770 - TRUWAVE2026-03-30 PRESSURE MONITORING SET
57460691955887 - TRUWAVE2026-03-30 PRESSURE MONITORING SET
00690103000382 - SWAN-GANZ TRUE SIZE2026-03-24 SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
50690103218287 - SWAN-GANZ VIP2026-03-24 SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER
50690103218607 - SWAN-GANZ TRUE SIZE2026-03-24 TRUE SIZE THERMODILUTION CATHETER
50690103218621 - SWAN-GANZ TRUE SIZE2026-03-24 TRUE SIZE CATHETER DOUBLE LUMEN
50690103218638 - SWAN-GANZ TRUE SIZE2026-03-24 TRUE SIZE MONITORING CATHETER TRIPLE LUMEN
00690103221312 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system2026-02-25 Pulmonic Delivery System - 20 mm (Gen 2) (US)
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.