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Medegen Medical Products, LLC

FDA UDI

Class I (US FDA UDI)

by Medegen Medical Products

Identity

Trade Name
Medegen Medical Products, LLC FDA UDI
Generic Name
Non-evacuated urine specimen container IVD, no additive FDA UDI
Device Name
Container Spec 6.5oz Spt Trns w/Lid 500/ FDA UDI
Model / Reference
M4646 FDA UDI
Description
Container Spec 6.5oz Spt Trns w/Lid 500/ FDA UDI

Identifiers

Primary DI / UDI-DI
00700812002048 FDA UDI
FDA Product Code
NNI FDA UDI
GMDN Term
Non-evacuated urine specimen container IVD, no additive 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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Non-evacuated urine specimen container IVD, no additive

Medegen Medical Products, LLC by Medegen Medical Products — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-evacuated urine specimen container IVD, no additive.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medegen Medical Products

Sources (1)

  • FDA UDI 38026eb9-903f-45ee-a985-713882f09e9a 33 fields · synced Jun 8, 2026