TrueCare Biomedix

GUDID 20850789007301

Truecare Biomedix - USA

Intravenous administration set Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive
Primary Device ID20850789007301
NIH Device Record Keye7dd2d6b-9748-441b-9a27-e96855b53b8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrueCare Biomedix
Version Model NumberTCBEXT004
Company DUNS005457284
Company NameTruecare Biomedix - USA
Device Count10
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 Numbertrue
Manufacturing Datetrue
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
GS100850789007307 [Unit of Use]
GS120850789007301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-09-23

On-Brand Devices [TrueCare Biomedix]

30850789007032TCBINF044G
20850789007349TCBPTTH-2LL
20850789007318TCBINF6419
20850789007301TCBEXT004
20850789007295TCBEXT003
20850789007288TCBEXT001
20850789007271TCBPTT331
20850789007264TCBPTT063
20850789007257TCBPTT062
20850789007240TCBPTT013S
20850789007233TCBPTT021
20850789007226TCBPTTPS1
20850789007219TCBPTT001
20850789007202TCBSYR60L-30
20850789007196TCBSYR60C-30
20850789007103TCBINF6481
20850789007097TCBINF6571
20850789007080TCBINF6537
20850789007073TCBINF6480
20850789007066TCBINF6519
20850789007059TCBINF6200
20850789007042TCBINF621
20850789007035TCBINF044G
20850789007028TCBINF033G
20850789007011TCBINF022AE
20850789007004TCBINF001
10850789007342TCBPTTH-2LL
10850789007335TCBSYR20B
10850789007328TCBSYR10B
10850789007311TCBINF6419
10850789007304TCBEXT004
10850789007298TCBEXT003
10850789007281TCBEXT001
10850789007274TCBPTT331
10850789007267TCBPTT063
10850789007250TCBPTT062
10850789007243TCBPTT013S
10850789007229TCBPTTPS1
10850789007212TCBPTT001
10850789007205TCBSYR60L-30
10850789007199TCBSYR60C-30
10850789007137TCBSYR3B
10850789007106TCBINF6481
10850789007090TCBINF6571
10850789007083TCBINF6537
10850789007076TCBINF6480
10850789007069TCBINF6519
10850789007052TCBINF6200
10850789007045TCBINF621
10850789007021TCBINF033G

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