SWAN-GANZ HI-SHORE TRUE SIZE 141F7

GUDID 00690103000504

SWAN-GANZ HI-SHORE TRUE SIZE THERMODILUTION CATHETER

Edwards Lifesciences LLC

Pulmonary artery catheter, thermal dilution

Primary Device ID	00690103000504
NIH Device Record Key	88f69ba1-c932-4dac-a089-b9c13615d378
Commercial Distribution Status	In Commercial Distribution
Brand Name	SWAN-GANZ HI-SHORE TRUE SIZE
Version Model Number	141F7
Catalog Number	141F7
Company DUNS	134139174
Company Name	Edwards Lifesciences LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	true
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
Phone	+1(800)822-9637
Email	tech_support@edwards.com

Device Dimensions

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Device Size Text, specify	0
Device Size Text, specify	0
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Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0
Device Size Text, specify	0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103000504 [Primary]
GS1	50690103000509 [Package] Package: Shipper [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160084

FDA Product Code

DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-12-11
Device Publish Date	2016-09-03

On-Brand Devices [SWAN-GANZ HI-SHORE TRUE SIZE]

00690103017830	HI TORQUE SG FLOW DIRECTED MONIT CATH W/ BONDED BALLOON
00690103017823	SWAN-GANZ TRUE SIZE HI-SHORE MONITORING "T" TIP CATHETER
00690103000504	SWAN-GANZ HI-SHORE TRUE SIZE THERMODILUTION CATHETER