VYGON CMS-8000

GUDID 38498840006512

NEEDLELESS CONNECTOR BIONECTOR

Vygon Corporation

Neutral-pressure intravenous line needleless valve-connector Neutral-pressure intravenous line needleless valve-connector Neutral-pressure intravenous line needleless valve-connector
Primary Device ID38498840006512
NIH Device Record Keyae4ba640-bfc1-4484-a39d-2a0ca6c6a369
Commercial Distribution StatusIn Commercial Distribution
Brand NameVYGON
Version Model NumberCMS-8000
Catalog NumberCMS-8000
Company DUNS120818216
Company NameVygon Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108498840006511 [Primary]
GS108498840006511 [Primary]
GS108498840006511 [Primary]
GS138498840006512 [Package]
Contains: 08498840006511
Package: [100 Units]
In Commercial Distribution
GS138498840006512 [Package]
Contains: 08498840006511
Package: [100 Units]
In Commercial Distribution
GS138498840006512 [Package]
Contains: 08498840006511
Package: [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOZCatheter,intravascular,therapeutic,short-term less than 30 days
FOZCatheter,intravascular,therapeutic,short-term less than 30 days
FOZCatheter,intravascular,therapeutic,short-term less than 30 days

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-19
Device Publish Date2016-08-05

On-Brand Devices [VYGON]

38498840011929MARKED NITI/AU GUIDEWIRE, 0/018" X 130CM
38498840011905MARKED NITINOL GUIDEWIRE, 0.018" X 80CM
384988400122163.5F X 5CM PTFE TEARAWAY INTRODUCER
38498840011912STAINLESS STEEL GUIDEWIRE, 0.018" X 80CM
38498840011899NITI/AU GUIDEWIRE, 0.018" X 70CM
38498840011882NITI/SS GUIDEWIRE, 0.018" X 45CM
38498840011875MARKED NITI/AU GUIDEWIRE, 0.018" X 45CM
384988400118135.5F X 10CM PTFE TEARAWAY INTRODUCER
384988400118064.5F X 10CM PTFE TEARAWAY INTRODUCER
384988400117906F X 7CM PTFE TEARAWAY INTRODUCER
384988400117835.5F X 7CM PTFE TEARAWAY INTRODUCER
384988400117764.0F X 7CM PTFE TEARAWAY INTRODUCER
3849884001176921GA. X 7CM INTRODUCER NEEDLE
3849884001175221GA. X 4CM INTRODUCER NEEDLE
3849884001131821GA SAFETY NEEDLE, 7CM
3849884001130121GA SAFETY NEEDLE, 4CM
38498840012568ULTRASOUND IV START KIT
384988400122304" MICROBORE EXTENSION SET
384988400122233.5FR MST INSERTION KIT
38498840012193CENTRAL LINE DRESSING KIT
384988400118446.0FR MST INSERTION KIT
384988400118375.5FR MST INSERTION KIT
384988400118204.0FR MST INSERTION KIT
38498840012537PREP KIT
38498840012391PROCEDURE KIT
38498840012384PICC INSERTION TRAY
38498840012360VAD KIT W/ CHLORAPREP
38498840012353VAD ACCESS KIT
38498840012308VAD ACCESS KIT
38498840012278VAD ACCESS TRAY
38498840012254LEADERFLEX INSERTION KIT
38498840011936PREP KIT
38498840011677PROCEDURE TRAY
38498840011646PIV INSERTION KIT
38498840011363CENTRAL LINE KIT
38498840011226CENTRAL VENOUS CATHETER KIT
38498840011042PICC INSERTION TRAY
38498840011035LEADERFLEX INSERTION KIT
38498840010830LEADERFLEX INSERTION KIT
38498840010663CENTRAL LINE KIT
38498840010649PICC INSERTION TRAY
38498840010632PICC INSERTION TRAY
38498840010564NEONATAL PICC TRAY
38498840010502CENTRAL LINE KIT
38498840010496PICC/MIDLINE KIT
38498840010151LEADERFLEX INSERTION TRAY
38498840010144PICC LINE TRAY
38498840010076INSERTION TRAY
38498840010069MAXIMUM BARRIER TRAY
38498840010007PICC INSERTION TRAY

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