Churchill Medical Systems BHY-2010

GUDID 38498840010267

10" WINGED SAFETY INFUSION SET W/20 GA. X 1.0" HUBER NEEDLE AND NEEDLELESS Y-SITE

Vygon Corporation

Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set
Primary Device ID38498840010267
NIH Device Record Key9d1955dc-a745-439a-a4a1-c3ef46fedd0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameChurchill Medical Systems
Version Model NumberBHY-2010
Catalog NumberBHY-2010
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
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS108498840010266 [Primary]
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution
GS138498840010267 [Package]
Contains: 08498840010266
Package: [12 Units]
Discontinued: 2020-07-31
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular
FPASet, administration, intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-31
Device Publish Date2020-04-21

On-Brand Devices [Churchill Medical Systems]

3849884001054010" WINGED SAFETY INFUSION SET W/22 GA. X .75" HUBER NEEDLE AND NEEDLELESS Y-SITE
3849884001053310" WINGED SAFETY INFUSION SET W/22 GA. X .5" HUBER NEEDLE
3849884001052610" WINGED SAFETY INFUSION SET W/22 GA. X .75" HUBER NEEDLE
3849884001051910" WINGED SAFETY INFUSION SET W/20 GA. X .75" (19MM) HUBER NEEDLE
3849884001073110" WINGED SAFETY INFUSION SET W/20 GA. X 1.0" HUBER NEEDLE
3849884001038010" WINGED SAFETY INFUSION SET W/22 GA. X 1.0" HUBER NEEDLE AND NEEDLELESS Y-SITE
3849884001037310" WINGED SAFETY INFUSION SET W/20 GA. X .75" HUBER NEEDLE AND NEEDLELESS Y-SITE
3849884001026710" WINGED SAFETY INFUSION SET W/20 GA. X 1.0" HUBER NEEDLE AND NEEDLELESS Y-SITE

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