Combo Kit PXVMPL172

GUDID 50690103200312

Pressure Monitoring Set

Edwards Lifesciences LLC

Invasive-pressure external transducer, single-use
Primary Device ID50690103200312
NIH Device Record Key73f0670e-c685-4c0d-ae4c-e43def6d4e06
Commercial Distribution StatusIn Commercial Distribution
Brand NameCombo Kit
Version Model NumberPXVMPL172
Catalog NumberPXVMPL172
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
GS100690103200317 [Primary]
GS150690103200312 [Package]
Contains: 00690103200317
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-25
Device Publish Date2019-04-17

On-Brand Devices [Combo Kit]

50690103200329Pressure Monitoring Set
50690103200312Pressure Monitoring Set
50690103200305Pressure Monitoring Set

Trademark Results [Combo Kit]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COMBO KIT
COMBO KIT
81025476 1025476 Dead/Cancelled
Titillations Ltd.
0000-00-00
COMBO KIT
COMBO KIT
73549630 1392069 Dead/Cancelled
LA VOZ CORPORATION
1985-07-23

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