Identity
- Trade Name
- PureCeption 24 - Determination Bi-Layer Kit FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase In HEPES-buffered HTF FDA UDI
- Model / Reference
- ART-2024 FDA UDI
- Description
- PureCeption 24 - Determination Bi-Layer Kit. 6x12 mL each of 40% UPPER and 80% LOWER Phase In HEPES-buffered HTF FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937818583 FDA UDI
- FDA Product Code
- MQL FDA UDI
- GMDN Term
- IVF medium kit 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 kit
PureCeption 24 - Determination Bi-Layer Kit by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as IVF medium kit.
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- Ultra-Fast Vitri — KITAZATO CORPORATION · Class II
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- G-Vitri™ Vitrification media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
- Vitrification Media(VS solution) — KITAZATO CORPORATION · Class II
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI d25b026a-d599-458f-b6d8-c6932a0133e5 34 fields · synced Jun 9, 2026