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TrueCare Biomedix

FDA UDI

Class II (US FDA UDI)

by U.S. Infusion, LLC

Identity

Trade Name
TrueCare Biomedix FDA UDI
Generic Name
Basic intravenous administration set, noninvasive FDA UDI
Model / Reference
TCBSYR3B FDA UDI

Identifiers

Primary DI / UDI-DI
10850789007137 FDA UDI
510(k) Number
K083686 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
Basic intravenous administration set, noninvasive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

TrueCare Biomedix by U.S. Infusion, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K083686 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
U.S. Infusion, LLC

Sources (1)

  • FDA UDI d03989cb-bddb-42b9-9d4c-8f6b7a50fc31 34 fields · synced May 30, 2026