Sperm Preparation Medium

FDA UDI

Class II (US FDA UDI)

by Origio A/S

Identity

Trade Name: Sperm Preparation Medium FDA UDI
Generic Name: IVF medium FDA UDI
Device Name: Sperm Preparation Medium without phenol red. 60 ml FDA UDI
Model / Reference: 10690060D FDA UDI
Description: Sperm Preparation Medium without phenol red. 60 ml FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937800708 FDA UDI
510(k) Number: K991332 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: IVF medium

Sperm Preparation Medium by Origio A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as IVF medium.

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LifeGlobal® Media — LifeGlobal Group, LLC · Class II
Multipurpose Handling Medium®-Complete (MHM®-C) — FUJIFILM IRVINE SCIENTIFIC, INC. · Class II
CaseBioscience® — Casebioscience, Inc. · Class II
SpermFreeze SSP — Fertipro NV · Class II
Gems Blastocyst Medium — GENEA BIOMEDX PTY LTD · Class II

Cleared under the same submission

K991332 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Origio A/S

Sources (1)

FDA UDI 9bc745e0-4053-4152-a7ce-0fcc17bcc29b 35 fields · synced Jun 6, 2026