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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
General specimen container IVD, no additive/medium FDA UDI
Device Name
Bag: STB 8X8 2.0ml clr 1000/cs FDA UDI
Model / Reference
49-93 FDA UDI
Description
Bag: STB 8X8 2.0ml clr 1000/cs FDA UDI

Identifiers

Primary DI / UDI-DI
00700812010074 FDA UDI
FDA Product Code
NNI 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

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: General specimen container IVD, no additive/medium

Medegen Medical Products, LLC offers a high-quality Container for medical testing and analysis. This device is designed to be used for collecting and storing specimens from different body regions for in vitro diagnostic investigation.

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
Medegen Medical Products

Sources (1)

  • FDA UDI a023d193-d66c-42eb-840a-0417adf1b687 33 fields · synced Jul 30, 2026