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Samco™ Bio-Tite™, ST, 90mL, 48mm Midstream Kit with Funnel

FDA UDI

Class I (US FDA UDI)

by Nalge Nunc International Corporation

Identity

Trade Name
Samco™ Bio-Tite™, ST, 90mL, 48mm Midstream Kit with Funnel FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
90ML MIDSTREAM KITW/FUNNEL ST FDA UDI
Model / Reference
070001 FDA UDI
Description
90ML MIDSTREAM KITW/FUNNEL ST FDA UDI

Identifiers

Primary DI / UDI-DI
10850016060546 FDA UDI
FDA Product Code
FMH FDA UDI
GMDN Term
General specimen container IVD, no additive/medium 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

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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
Sterilization Method
Radiation Sterilization FDA UDI

Category: General specimen container IVD, no additive/medium

Samco™ Bio-Tite™, ST, 90mL, 48mm Midstream Kit with Funnel by Nalge Nunc International Corporation — Class I — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as General specimen container IVD, no additive/medium.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nalge Nunc International Corporation

Sources (1)

  • FDA UDI f72b98e9-a1a8-49d8-93e3-b78ef628b9cc 33 fields · synced Jun 9, 2026