Origio Gradient 90
ORIGIO Gradient 90 is a laboratory medium for separating motile sperm from an ejaculate using a density gradient. It is a colorless, viscous solution used in sperm preparation, with silane…
ORIGIO Gradient 90 is a laboratory medium for separating motile sperm from an ejaculate using a density gradient. It is a colorless, viscous solution used in sperm preparation, with silane silica providing the density needed for separation.
The formulation includes human serum albumin and gentamicin. Gradient 90 contains albumin at 5 mg/mL, and its specified density is 1.105 to 1.119 g/mL.
Listed Item
ORIGIO Gradient 90, 60 ml
Packaging and Stability
The solution is aseptically filtered and bottled in transparent PETG with an HDPE closure. Under recommended storage conditions, the unopened medium has a 36-week shelf life and remains stable for four weeks after opening.
Who Else Makes It
Concentrated in Guangdong (3), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Shenzhen VitaVitro Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Gimbo Medical Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
| Shandong Wego Ruisheng Medical Device Co., Ltd. | Weihai | Shandong | Manufacturer | 2 |
Record
| Listed by | Origio A/S, Denmark |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K153267 |
| Record published | 2018-04-18 |
| Record revised | 2018-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Protect from light |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 84010060D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LifeGlobal® Media | LifeGlobal Group, LLC | 93 |
| Sydney IVF | William A. Cook Australia PTY, Ltd. | 29 |
| LifeGlobal® Media | Coopersurgical, Inc. | 27 |
| VitaVitro | Shenzhen VitaVitro Biotech Co., Ltd. | 22 |
| Nidacon | Nidacon International AB | 19 |
| Sil-Select Plus Lower Layer | Fertipro NV | 8 |
| FertiCult Mineral Oil | Fertipro NV | 8 |
| Dewin | Donnevie Medical Technology (Shanghai) Co., Ltd. | 8 |
| SpermGrad | Vitrolife Sweden AB | 8 |
| Sequential Culture Media | Kitazato Corporation | 8 |
| Sperm Wash Medium | Invitrocare Inc | 7 |
| Enhance-S Plus | Vitrolife Inc. | 7 |
Showing 12 of 360. All products under Media, Reproductive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173624 | 2018-03-02 |
| K172197 | 2017-10-13 |
| K153267 | 2016-07-22 |
| K152932 | 2016-02-29 |
| K140317 | 2014-06-16 |
| K133912 | 2014-05-14 |
| K133387 | 2014-04-29 |
| K133707 | 2014-04-16 |
| K120136 | 2012-09-26 |
| K100367 | 2010-08-27 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | 510(k) number | 2024-02-16 | Class II | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development | 980 units |
| Coopersurgical, Inc. | 510(k) number | 2024-02-16 | Class II | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development | 2680 units |
| Coopersurgical, Inc. | 510(k) number | 2024-02-16 | Class II | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development | 770 units |
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.