PEDIASAT XT248KTP

GUDID 00690103197549

PEDIASAT OXIMETRY CATHETER KIT

Edwards Lifesciences LLC

Oximeter catheter, single-use
Primary Device ID00690103197549
NIH Device Record Key01d91040-3f7e-418a-9180-39a2ff0ec099
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEDIASAT
Version Model NumberXT248KTP
Catalog NumberXT248KTP
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
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

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103197549 [Primary]

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

On-Brand Devices [PEDIASAT]

00690103197570PEDIASAT OXIMETRY CATHETER KIT
00690103197563PEDIASAT OXIMETRY CATHETER KIT
00690103197556PEDIASAT OXIMETRY CATHETER KIT
00690103197549PEDIASAT OXIMETRY CATHETER KIT
00690103197532PEDIASAT OXIMETRY CATHETER SET
00690103197525PEDIASAT OXIMETRY CATHETER SET
00690103197518PEDIASAT OXIMETRY CATHETER SET
00690103197488PEDIASAT OXIMETRY CATHETER SET

Trademark Results [PEDIASAT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PEDIASAT
PEDIASAT
78700298 not registered Dead/Abandoned
Edwards Lifesciences Corporation
2005-08-25
PEDIASAT
PEDIASAT
78637927 3389845 Live/Registered
Edwards Lifesciences Corporation
2005-05-26

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