Fast Warm-NX is a dual buffered solution (HEPES and MOPS) of Continuous Single Culture Medium (CSCM) containing gentamicin sulfate, 20% (v/v) Dextran Serum Supplement (DSS), and 1.0M…
Fast Warm-NX is a dual buffered solution (HEPES and MOPS) of Continuous Single Culture Medium (CSCM) containing gentamicin sulfate, 20% (v/v) Dextran Serum Supplement (DSS), and 1.0M trehalose. DSS is a protein supplement consisting of 50mg/mL therapeutic grade Human Serum Albumin (HSA) and 20 mg/mL Dextran. DSS is used at 20% (v/v) in Fast Warm-NX for a final concentration of 10mg/mL HSA and 4mg/mL Dextran. Fast Warm-NX is intended for use in assisted reproductive procedures for the thawing of vitrified human blastocyst stage embryos.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
Record
Regulatory record for Fast Warm-NX with Gentamicin | Listed by | Irvine Scientific LLC, United States |
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K250445 |
| Record published | 2026-01-09 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 2 to 8 °C |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.