Identity
- Trade Name
- PureCeption 4 - Determination Kit FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- ART-2004: PureCeption 4 - Determination Kit with Sperm Washing Medium. (3x12 ml) ART-2016: PureCeption 16 - Determination Kit with Sperm Washing Medium. 4x(3x12 ml) FDA UDI
- Model / Reference
- ART-2004 FDA UDI
- Description
- ART-2004: PureCeption 4 - Determination Kit with Sperm Washing Medium. (3x12 ml) ART-2016: PureCeption 16 - Determination Kit with Sperm Washing Medium. 4x(3x12 ml) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937818521 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
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
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 4 - Determination Kit by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as IVF medium kit.
- Vitrification Media(BS solution) — KITAZATO CORPORATION · Class II
- Vit Kit - Freeze NX — FUJIFILM IRVINE SCIENTIFIC, INC. · Class II
- G-Vitri™ Warming media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
- ORIGIO Gradient 40/80 — Origio A/S · Class II
- Ultra-Fast Vitri — KITAZATO CORPORATION · Class II
- G-Vitri™ Warming media — Gimbo Medical Technology Shenzhen Co., Ltd. · Class II
- 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 5238d2bb-8c70-4b99-9340-e8b05a2ca802 34 fields · synced Jun 9, 2026