Origio Handling
ORIGIO Handling is a ready-to-use medium that supports gametes and embryos during assisted reproduction procedures performed outside a carbon dioxide incubator. It is used for handling,…
ORIGIO Handling is a ready-to-use medium that supports gametes and embryos during assisted reproduction procedures performed outside a carbon dioxide incubator. It is used for handling, washing and micromanipulation, including oocyte retrieval and follicle flushing.
The solution contains amino acids, energy substrates, salts, vitamins, buffers, human serum albumin and gentamicin. Formulations are supplied with or without phenol red, in 60 or 125 mL bottles.
Listed Item
Handling media with phenol red 125 ml
Laboratory Preparation
The medium supports procedures such as ICSI, assisted hatching and trophectoderm biopsy. It is prewarmed to 37 degrees Celsius before use, except for sperm washing, where room-temperature warming is specified.
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) | K173624 |
| Record published | 2018-09-23 |
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 |
|---|---|---|
| 83100060D | In distribution | |
| 83110060D | In distribution | |
| 83100125D | In distribution | |
| 83110125D | 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.