TRUWAVE X 3 (3 CC)/VAMP PLUS (215 CM) T100671M

GUDID 57460691959496

PRESSURE MONITORING SET

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use
Primary Device ID57460691959496
NIH Device Record Keyb2c8bea5-e334-4adb-8478-c8e88514472d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRUWAVE X 3 (3 CC)/VAMP PLUS (215 CM)
Version Model NumberT100671M
Catalog NumberT100671M
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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

Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107460691959491 [Primary]
GS157460691959496 [Package]
Contains: 07460691959491
Package: Shipper [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, Continuous Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-04
Device Publish Date2020-04-24

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