Premium Plus

FDA UDI

Class I (US FDA UDI)

by Premium Plus International Limited

Identity

Trade Name: Premium Plus FDA UDI
Generic Name: Specimen container mailer, non-insulated FDA UDI
Device Name: Guard Box FDA UDI
Model / Reference: 602-GREEN FDA UDI
Description: Guard Box FDA UDI

Identifiers

Primary DI / UDI-DI: D838602GREEN2 FDA UDI
FDA Product Code: NNI FDA UDI
GMDN Term: Specimen container mailer, non-insulated 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Specimen container mailer, non-insulated

Premium Plus by Premium Plus International Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Premium Plus International Limited

Sources (1)

FDA UDI b1b63480-ab7e-401e-9e6d-b086a23b3c99 33 fields · synced May 30, 2026