Identity
- Trade Name
- SPERMCARE Upper Layer - Gradient System FDA UDI
- Generic Name
- IVF medium FDA UDI
- Device Name
- SPERMCARE Upper Layer - Gradient System is a 45% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Upper Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures. FDA UDI
- Model / Reference
- 2221-50 FDA UDI
- Description
- SPERMCARE Upper Layer - Gradient System is a 45% solution of silane-coated silica particles in Earle's Balanced Salts Solution (EBSS) with HEPES (pH buffer). Available in 45%, 90% and 100%. SPERMCARE Upper Layer - Gradient System is used for separation and purification of human sperm for assisted reproduction procedures. FDA UDI
Identifiers
- Catalog Number
- 2221-50 FDA UDI
- Primary DI / UDI-DI
- 00859268006183 FDA UDI
- 510(k) Number
- 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
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
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
SPERMCARE Upper Layer - Gradient System by Invitrocare, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as IVF medium.
- DEWIN — DonneVie Medical Technology(Shanghai)Co.Ltd · Class II
- Sepa Sperm Solution — KITAZATO CORPORATION · Class II
- 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
- Sperm Freezing Medium — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
Cleared under the same submission
K053494 also covers:
- Sil-Select Stock — Fertipro NV
- Sil-Select Stock — Fertipro NV
- Sil-Select Stock — Fertipro NV
- SpermFreeze — Fertipro NV
- SpermFreeze — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- SpermFreeze SSP — Fertipro NV
- GM501 Gradient 100% — HAMILTON THORNE, Inc.
- GM501 Gradient 100% — HAMILTON THORNE, Inc.
- GM501 Gradient 100% — HAMILTON THORNE, Inc.
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 9df8b36e-70a5-4d7c-ac5d-32d3cbea6dc1 35 fields · synced Jun 1, 2026