VAMP JR. 7 IN (17 CM) VJL0063

GUDID 50690103198237

BLOOD MANAGEMENT SYSTEM

Edwards Lifesciences LLC

Arterial blood sampling kit
Primary Device ID50690103198237
NIH Device Record Key287573af-a270-451b-a6b2-027d60a021dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameVAMP JR. 7 IN (17 CM)
Version Model NumberVJL0063
Catalog NumberVJL0063
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103198232 [Primary]
GS150690103198237 [Package]
Contains: 00690103198232
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 Date2020-04-24
Device Publish Date2020-04-16

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00690103166989 - HEART VALVE ACCESSOR2024-10-28 MITRAL SIZER HANDLE
00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 462024-10-28 RING HANDLE - EXTENDED 4"
00690103186437 - FLEXIBLE HANDLE2024-10-28 FLEXIBLE HANDLE
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