EDWARDS DILATOR KIT 9100DKSA

GUDID 00690103192391

EDWARDS DILATOR KIT

Edwards Lifesciences LLC

Vascular catheter introduction set, nonimplantable
Primary Device ID00690103192391
NIH Device Record Keyeae3668e-b0c5-42f1-98e3-43b5bb1c3a8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDWARDS DILATOR KIT
Version Model Number9100DKSA
Catalog Number9100DKSA
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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
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
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
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
GS100690103192391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-08-26
Device Publish Date2015-12-01

Devices Manufactured by Edwards Lifesciences LLC

50690103000073 - CO-SET INJECTATE ICE BUCKET2025-07-24 CO-SET INJECTATE ICE BUCKET 6 PER CASE
00690103002546 - CLAMP FOR DPT HOLDER2025-07-23 PRESSURE MONITORING ACCESSORY
50690103197902 - TRUCLIP2025-07-23 TRUCLIP
50690103210823 - Combo Kits2025-07-23 Pressure Monitoring Set
00690103216998 - HEMOSPHERE2025-07-23 Mindray OEM Pressure Smart Cable
00690103219111 - Cable2025-07-23 PHILIPS CARDIAC OUTPUT TEMPERATURE PROBE
07460691949867 - PRESSURE MONITORING ACCESSORY2025-07-23 PRESSURE MONITORING ACCESSORY
57460691956143 - TruWave2025-07-23 PRESSURE MONITORING ACCESSORY

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.