TRUWAVE, VAMP PXVK0797

GUDID 07460691954878

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use
Primary Device ID07460691954878
NIH Device Record Key5b89f992-71af-4761-b8d2-75bd1e0c4576
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUWAVE, VAMP
Version Model NumberPXVK0797
Catalog NumberPXVK0797
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Dimensions

Total Volume3 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107460691954878 [Primary]
GS157460691954873 [Package]
Package: Shipper [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXOTRANSDUCER, PRESSURE, CATHETER TIP

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-21
Device Publish Date2016-09-03

On-Brand Devices [TRUWAVE, VAMP]

00690103162141PRESSURE MONITORING SET
00690103161830PRESSURE MONITORING SET
00690103016802PRESSURE MONITORING SET
00690103016765PRESSURE MONITORING SET
00690103016581PRESSURE MONITORING KIT - STERILE
00690103011494PRESSURE MONITORING SET
07460691959439PRESSURE MONITORING SET
07460691958760PRESSURE MONITORING KIT - STERILE
07460691958753PRESSURE MONITORING KIT - STERILE
07460691958661PRESSURE MONITORING KIT - STERILE
07460691958340PRESSURE MONITORING KIT - STERILE
07460691957879PRESSURE MONITORING KIT - STERILE
07460691957862PRESSURE MONITORING SET
07460691957671PRESSURE MONITORING KIT - STERILE
07460691957534PRESSURE MONITORING KIT - STERILE
07460691957527PRESSURE MONITORING KIT - STERILE
07460691956667PRESSURE MONITORING SET
07460691956575PRESSURE MONITORING KIT - STERILE
07460691956216PRESSURE MONITORING KIT - STERILE
07460691956209PRESSURE MONITORING KIT - STERILE
07460691955431PRESSURE MONITORING SET
07460691955127PRESSURE MONITORING SET
07460691955110PRESSURE MONITORING SET
07460691955103PRESSURE MONITORING SET
07460691955097PRESSURE MONITORING SET
07460691955080PRESSURE MONITORING SET
07460691955073PRESSURE MONITORING SET
07460691955035PRESSURE MONITORING KIT - STERILE
07460691955028PRESSURE MONITORING KIT
07460691955004PRESSURE MONITORING KIT - STERILE
07460691954991PRESSURE MONITORING KIT - STERILE
07460691954960PRESSURE MONITORING SET
07460691954953PRESSURE MONITORING SET
07460691954946PRESSURE MONITORING KIT - STERILE
07460691954878PRESSURE MONITORING SET
07460691954854PRESSURE MONITORING KIT - STERILE
07460691954816PRESSURE MONITORING SET
07460691954809PRESSURE MONITORING SET
07460691954748PRESSURE MONITORING SET
07460691954731PRESSURE MONITORING KIT - STERILE
07460691954656PRESSURE MONITORING KIT - STERILE
07460691954649PRESSURE MONITORING SET
07460691954632PRESSURE MONITORING KIT - STERILE
07460691954618PRESSURE MONITORING SET
07460691954601PRESSURE MONITORING SET
07460691954571PRESSURE MONITORING KIT - STERILE
07460691954564PRESSURE MONITORING SET
07460691954557PRESSURE MONITORING SET
07460691954540PRESSURE MONITORING SET
07460691954533PRESSURE MONITORING KIT - STERILE

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