TrueCare Biomedix

GUDID 20850789007714

U.S. Infusion, LLC

Basic intravenous administration set, noninvasive
Primary Device ID20850789007714
NIH Device Record Key49b17603-d85d-4589-8a36-51e6a687e4d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrueCare Biomedix
Version Model NumberTCBEXT1.2
Company DUNS005457284
Company NameU.S. Infusion, LLC
Device Count50
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 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
GS100850789007710 [Unit of Use]
GS110850789007717 [Primary]
GS120850789007714 [Package]
Contains: 10850789007717
Package: Case [500 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


[20850789007714]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-08-04
Device Publish Date2022-12-31

On-Brand Devices [TrueCare Biomedix ]

20850789007721TCBEXT0.2
20850789007714TCBEXT1.2
20850789007707TCBINF6481NC

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