Origio Sequential Blast
Origio Sequential Blast is a ready-to-use culture medium for human embryos from the four-to-eight-cell stage through the blastocyst stage. It can also be used for embryo transfer by…
Origio Sequential Blast is a ready-to-use culture medium for human embryos from the four-to-eight-cell stage through the blastocyst stage. It can also be used for embryo transfer by assisted-reproduction professionals.
The nonviscous solution is available with or without phenol red. Its formulation includes physiological salts, amino acids, energy sources and bicarbonate buffer to support the relevant development stage.
Listed Item
ORIGIO Sequential Blast with phenol red. 60 ml
Bottle Formats
The aseptically filtered medium is supplied in 10 mL or 60 mL PETG bottles with high-density polyethylene closures. The phenol-red version is light pink, while the version without it is colorless.
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) | K133387 |
| Record published | 2017-07-18 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from light; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 83050060D | In distribution | |
| 83060060D | In distribution | |
| 83060010D | In distribution | |
| 83050010D | 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 |
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.