Regard™

GUDID 20326053100752

RESOURCE OPTIMIZATION & INNOVATION, L.L.C.

Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter Fluid/device delivery cardiac catheter
Primary Device ID20326053100752
NIH Device Record Keybfec9cc3-e103-4491-84a5-1af485172eba
Commercial Distribution Discontinuation2020-07-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameRegard™
Version Model NumberHT0074
Company DUNS945020902
Company NameRESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS110326053100755 [Primary]
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution
GS120326053100752 [Package]
Contains: 10326053100755
Package: [3 Units]
Discontinued: 2020-07-30
Not in Commercial Distribution

FDA Product Code

OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit
OESCardiac Catheterization Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-07-31
Device Publish Date2016-12-21

On-Brand Devices [Regard™]

10326053105736T100-CS
10326053105699PEDIATRIC-PHILIPS
10326053105682PEDIATRIC-PHYSIO
10326053105668PEDIATRIC-ZOLL
10326053105651PED-100
10326053105514T100AC-PHILIPS
10326053105507T100AC-PHYSIO
10326053105491T100AC-ZOLL
10326053105484T100AC
20326053116050SP1051
20326053114360GS0982
20326053108710GS0439
10326053106108C100LOAC-PHYSIO
10326053106092C100LOAC-PHILIPS
10326053106085C100LOAC-ZOLL
10326053106078C100LOAC
10326053106061T100LOAC-PHYSIO
10326053106054T100LOAC-PHILIPS
10326053106047T100LOAC-ZOLL
10326053106030T100LOAC
10326053106023C100AC-PHILIPS
10326053106016C100AC-PHYSIO
10326053106009C100AC-ZOLL
20326053114926AN1026
20326053108826GS0751
20326053100967OR0095
20326053116159GY1058
20326053114117CV0965
20326053108482HT0333
20326053103548OB0166
20326053101001EY0099
20326053108284GS0441
20326053113776GY0941
20326053112656GS0810
20326053100479LD0108
20326053116630OR1083
20326053112045GS0264
20326053115336AN1041
20326053113899NU0909
20326053110720LD0399
20326053100233LD0025
20326053109397EY0266
20326053116708OR1078
20326053116692OR1077
20326053113837LD0928
20326053113578OR0943
20326053100974NU0096
20326053100332GS0037
20326053113110GS0864
20326053115428GS1043

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