EDWARDS OXIMETRY CENTRAL VENOUS CATHETER X3820KT

GUDID 00690103197457

EDWARDS OXIMETRY CENTRAL VENOUS CATHETER KIT

Edwards Lifesciences LLC

Oximeter catheter, single-use
Primary Device ID00690103197457
NIH Device Record Key8aececb2-8407-43b7-bed2-cb5a66e34493
Commercial Distribution StatusIn Commercial Distribution
Brand NameEDWARDS OXIMETRY CENTRAL VENOUS CATHETER
Version Model NumberX3820KT
Catalog NumberX3820KT
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latextrue
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 COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN COOL, DRY PLACE

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103197457 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-03

On-Brand Devices [EDWARDS OXIMETRY CENTRAL VENOUS CATHETER]

00690103197594EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
00690103197587EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
00690103197457EDWARDS OXIMETRY CENTRAL VENOUS CATHETER KIT
00690103197440EDWARDS OXIMETRY CENTRAL VENOUS CATHETER KIT
00690103197433EDWARDS OXIMETRY CENTRAL VENOUS CATHETER
00690103197204EDWARDS OXIMETRY OLIGON CENTRAL VENOUS CATHETER KIT
00690103197181EDWARDS OXIMETRY OLIGON CENTRAL VENOUS CATHETER KIT
00690103197174EDWARDS OXIMETRY OLIGON CENTRAL VENOUS CATHETER KIT
00690103195309EDWARDS OXIMETRY OLIGON CENTRAL VENOUS CATHETER KIT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.