SPERMCARE / SPERM WASH - Gradient System

FDA UDI

Class II (US FDA UDI)

by Invitrocare, Incorporated

Identity

Trade Name: SPERMCARE / SPERM WASH - Gradient System FDA UDI
Generic Name: IVF medium FDA UDI
Device Name: SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Lower Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures. SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere. FDA UDI
Model / Reference: 2224 FDA UDI
Description: SPERMCARE Lower Layer - Gradient System is a 90% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Lower Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures. SPERM WASH MEDIUM is a synthetic, defined culture medium supplemented with 5mg/ml human serum albumin and is intended for use in assisted reproductive technology procedures. It has been formulated to mimic the composition of the fluid found in fallopian tubes as defined by Quinn etal (Quinn P, Kerin JF, Warnes GM: Fertil Steril 1985;44:493-498). SPERM WASH MEDIUM uses a combined sodium bicarbonate/HEPES ([4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid]) buffering system and is appropriate for those procedures that do not use a carbon dioxide atmosphere. FDA UDI

Identifiers

Catalog Number: 2224 FDA UDI
Primary DI / UDI-DI: 10859268006241 FDA UDI
510(k) Number: K000989 FDA UDI
K053494 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

SPERMCARE / SPERM WASH - Gradient System by Invitrocare, Incorporated — 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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Sperm Freezing Medium — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II

Cleared under the same submission

K000989 also covers:

K053494 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: Invitrocare, Incorporated

Sources (1)

FDA UDI 67887bb7-be6c-4a91-bef3-998e6b29db46 35 fields · synced May 30, 2026