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Globe Scientific

FDA UDI

Class I (US FDA UDI)

by Globe Scientific, Llc

Identity

Trade Name
Globe Scientific FDA UDI
Generic Name
Drug-testing urine specimen container IVD FDA UDI
Device Name
Container: Tite-Rite, 120mL (4oz), PP, STERILE, Attached Natural Screw Cap, ID Label with Tab Seal and Temperature Strip, Graduated FDA UDI
Model / Reference
6528TP FDA UDI
Description
Container: Tite-Rite, 120mL (4oz), PP, STERILE, Attached Natural Screw Cap, ID Label with Tab Seal and Temperature Strip, Graduated FDA UDI

Identifiers

Primary DI / UDI-DI
00840095608329 FDA UDI
FDA Product Code
FMH FDA UDI
GMDN Term
Drug-testing urine specimen container IVD 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

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

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: Drug-testing urine specimen container IVD

Globe Scientific by Globe Scientific, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Drug-testing urine specimen container IVD.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Globe Scientific, Llc

Sources (1)

  • FDA UDI f114d98d-9faf-41ab-a275-4b7c1f119eb2 33 fields · synced May 30, 2026