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DeRoyal

FDA UDI

Class I (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name
DeRoyal FDA UDI
Generic Name
Blood collection set, invasive FDA UDI
Device Name
ST BLOOD DRAW ACC KIT FDA UDI
Model / Reference
47-500 FDA UDI
Description
ST BLOOD DRAW ACC KIT FDA UDI

Identifiers

Catalog Number
47-500 FDA UDI
Primary DI / UDI-DI
00749756044387 FDA UDI
FDA Product Code
OIB FDA UDI
GMDN Term
Blood collection set, invasive FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
864.3250 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

Yes

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

Category: Blood collection set, invasive

DeRoyal by Deroyal Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood collection set, invasive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 5410f29c-4fe0-438e-b8ff-141033924c39 34 fields · synced Jun 8, 2026