TRUWAVE CABLES 896031022

GUDID 00690103210507

CBLASY,5 PIN/NIHON KHODEN,MDR

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use

Primary Device ID	00690103210507
NIH Device Record Key	3b8c43d3-d341-44a0-80fb-9ad253837c26
Commercial Distribution Status	In Commercial Distribution
Brand Name	TRUWAVE CABLES
Version Model Number	PX1800
Catalog Number	896031022
Company DUNS	134139174
Company Name	Edwards Lifesciences LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com
Phone	+1(800)822-9637
Email	tech_support@edwards.com

Device Dimensions

Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch
Length	162 Inch

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, Specify	Between 0 and 0 *STORE IN A COOL, DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103210507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142749

FDA Product Code

DXO	Transducer, Pressure, Catheter Tip

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-08-03
Device Publish Date	2020-07-24

On-Brand Devices [TRUWAVE CABLES]

00690103210552	CABLE ASSY, EW SIEMENS, MDR
00690103210484	CABLE ASSY, 6 PIN/MS3106, MDR
00690103210590	CABLE ASSY,EW,BI,GE,ROHS,MDR
00690103210583	CABLE ASSY, TRUWAVE, ROHS, MDR
00690103210576	CBL ASY,EW 12PN/FKDA DNSHI,MDR
00690103210538	CBL ASSY,4 PIN/AMPHENOL,MDR
00690103210521	CBL ASSY,12 PIN/KONTRON,MDR
00690103210514	CABLE ASSY,EW TRUWAVE,ROHS,MDR
00690103210507	CBLASY,5 PIN/NIHON KHODEN,MDR
00690103210491	CABLE ASSY, TRUWAVE, ROHS, MDR
00690103210477	CABLE ASSY,10PIN/SIEMENS,MDR
00690103210460	CABLE ASSY,10PIN/SIEMENS,MDR
00690103218305	CBL ASSY,MARQUETTE/RCTN,ROHS
00690103210613	CABLE ASSY, TRUWAVE, MDR
00690103210606	CABLE ASSY, TRUWAVE, MDR
00690103210545	CABLE ASSEMBLY, EW, ROHS, MDR