Phosphate Buffered Saline With Ca, Mg, Glucose, Pyrovate, Phenol Red
Phosphate Buffered Saline with Ca, Mg, Glucose, Pyrovate, Phenol Red. 500 ml
4manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
10recalls on this code
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 | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | MQL |
| Device type | Media, Reproductive |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6180 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-07-28 |
| Record revised | 2025-09-26 (version 3) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ART-4012 | 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 |
|---|---|
| K173731 | 2018-03-02 |
| K170560 | 2017-04-04 |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-02-16 | Class II | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development | 980 units | |
| 2024-02-16 | Class II | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development | 2680 units | |
| 2024-02-16 | Class II | Under Investigation by firm | Low concentration of sodium pyruvate in the wash could compromise gamete development | 770 units | |
| 2023-12-20 | Class II | Under Investigation by firm | The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage. | 994 total (481 US; 513 OUS) | |
| 2023-02-13 | Class II | Labeling Change Control | It has come to CooperSurgical’s attention that the affected Product may contain a medium other than the Global Total LP single step medium which does not contain the protein source required for embryo culture and development. | 190 units | |
| 2022-12-15 | Class II | Labeling Change Control | The affected product may contain a medium other than the Biopsy Medium. There is a risk that use of the Product from this lot could cause degradation of the embryo. | 489 units | |
| 2022-06-13 | Class II | Error in labeling | There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version. | 403 units | |
| 2020-09-08 | Class II | Under Investigation by firm | There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrificati | 531 total boxes | 2021-01-11 |
| 2016-08-25 | Class III | Packaging change control | Products contain international package insert and not the correct USA package insert | 1 unit | 2017-02-01 |
| 2016-08-25 | Class III | Packaging change control | Products contain international package insert and not the correct USA package insert | 4 units | 2017-02-01 |
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.