Identity
- Trade Name
- SAGE Vitrification Warming Kit XL FDA UDI
- Generic Name
- IVF medium kit FDA UDI
- Device Name
- SAGE Vitrification Warming Kit , ART-8034 (in plastic cryo vials): 8x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution. 2x2 ml of 0,5 M ART-8031-B Sucrose Warming Solution. 2x2 ml of ART-8031-C MOPS Solution. FDA UDI
- Model / Reference
- ART-8034 FDA UDI
- Description
- SAGE Vitrification Warming Kit , ART-8034 (in plastic cryo vials): 8x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution. 2x2 ml of 0,5 M ART-8031-B Sucrose Warming Solution. 2x2 ml of ART-8031-C MOPS Solution. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937027138 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
Yes
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
SAGE Vitrification Warming Kit XL 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
Cleared under the same submission
K170560 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 238edfeb-3955-4656-9215-8b9f6d508fe7 35 fields · synced Jun 9, 2026