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ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration)

FDA UDI

Class II (US FDA UDI)

by Artsmedia Denmark ApS

Identity

Trade Name
ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration) FDA UDI
Generic Name
IVF medium FDA UDI
Device Name
Intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes. FDA UDI
Model / Reference
20 ml FDA UDI
Description
Intended for retrieval of human oocytes by follicular aspiration or flushing. The medium can also be used for washing of oocytes. FDA UDI

Identifiers

Catalog Number
502020 FDA UDI
Primary DI / UDI-DI
05745000591138 FDA UDI
FDA Product Code
MQL FDA UDI
GMDN Term
IVF medium FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.6180 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: IVF medium

ARTSMedia Oocyte Aspiration Medium (AM Oocyte Aspiration) by Artsmedia Denmark ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as IVF medium.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI f49a0ede-6a9f-4b8c-998c-ca8172667e2f 34 fields · synced May 30, 2026