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Regard™

FDA UDI

Class II (US FDA UDI)

by Resource Optimization & Innovation, L.l.c.

Identity

Trade Name
Regard™ FDA UDI
Generic Name
Vascular catheterization support/maintenance kit, non-medicated FDA UDI
Device Name
Central Line Infant Kit FDA UDI
Model / Reference
303408 FDA UDI
Description
Central Line Infant Kit FDA UDI

Identifiers

Primary DI / UDI-DI
20326053105306 FDA UDI
FDA Product Code
PEZ FDA UDI
GMDN Term
Vascular catheterization support/maintenance kit, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Vascular catheterization support/maintenance kit, non-medicated

Regard™ by Resource Optimization & Innovation, L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular catheterization support/maintenance kit, non-medicated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Resource Optimization & Innovation, L.l.c.

Sources (1)

  • FDA UDI 822ae1b1-2c38-4ee2-aa24-b646c05ed4c1 33 fields · synced May 31, 2026