Product code MQL
- Product
- Radiation Emitting Electronic Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical De
- Definition
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co
- Description
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; Var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
- Regulation number
- Radiation type
- Radiation Emitting Electronic Product Codes // Qui
- Applicable standards
- Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Radiation Emitting Electronic Product Codes Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_lang', SrcUrl: Unescape('mp_js_orgin_url'), Init: Function(){ If (MP.UrlLang.indexOf('p_js_')==1) { MP.SrcUrl=window.top.document.location.href; MP.UrlLang=MP.SrcLang; } }, GetCookie: Function(name){ Var Start=document.cookie.indexOf(name+'='); If(start < 0) Return Null; Start=start+name.length+1; Var End=document.cookie.indexOf(';', Start); If(end < 0) End=document.cookie.length; While (document.cookie.charAt(start)==' '){ Start++; } Return Unescape(document.cookie.substring(start,end)); }, SetCookie: Function(name,value,path,domain){ Var Cookie=name+'='+escape(value); If(path)cookie+='; Path='+path; If(domain)cookie+='; Domain='+domain; Var Now=new Date(); Now.setTime(now.getTime()+1000*60*60*24*365); Cookie+='; Expires='+now.toUTCString(); Document.cookie=cookie; }, SwitchLanguage: Function(lang){ If(lang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[lang]+'/'+MP.SrcLang+lang+'/?1023749632;'+encodeURIComponent(MP.SrcUrl); Document.body.appendChild(script); } Else If(lang==MP.SrcLang && MP.UrlLang!=MP.SrcLang){ Var Script=document.createElement('SCRIPT'); Script.src=location.protocol+'//'+MP.Domains[MP.UrlLang]+'/'+MP.SrcLang+MP.UrlLang+'/?1023749634;'+encodeURIComponent(location.href); Document.body.appendChild(script); } Return False; }, SwitchToLang: Function(url) { Window.top.location.href=url; } }; var Addthis_config = {data_track_clickback: True, Ui_508_compliant: True, Services_compact: 'facebook, Twitter, Linkedin, Pinterest_share, Email', Services_exclude: 'print', Image_container: "#user_provided" } ; FDA Home Medical Devices Databases -
Current FDA Classification
- Device name
- Media, Reproductive
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.6180
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
Related Records
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260248 | Ultra-Fast Warm | Kitazato Corporation | 2026-04-28 |
| K252672 | CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5) | Casebioscience, Inc. | 2026-02-20 |
| K250445 | Fast Warm - NX | Fujifilm Irvine Scientific | 2025-09-12 |
| K251637 | Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-08-27 |
| K251305 | Ultra-Fast Vitri; Ultra-Fast Warm | Kitazato Corporation | 2025-08-26 |
| K242640 | FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin | Fertipro NV | 2025-05-30 |
| K242561 | Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2025-04-10 |
| K242089 | Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) | Jiangsu Ruifuda Medical Device Co., Ltd. | 2025-04-10 |
| K242107 | CaseMONO Culture (CMON); CaseMONO w/HEPES (WHMO); CaseBioscience® HTF (HTFC); CaseBioscience® HTF w/HEPES (HHTF) | Casebioscience, Inc. | 2025-03-21 |
| K241833 | V-GRAD | Vitromed GmbH | 2025-03-21 |
| K242043 | Sperm Freezing Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | 2025-01-08 |
| K241132 | ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) | Artsmedia Denmark Aps | 2024-12-18 |
| K241095 | ARTSMedia Semen Wash Medium | Artsmedia Denmark Aps | 2024-12-18 |
| K242968 | Giftlife® Single-Step Medium Plus | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-11-22 |
| K240176 | V-VITFREEZE and V-VITWARM | Vitromed GmbH | 2024-09-13 |
| K233846 | Vitrification Solution Set and Warming Solution Set | Ecmpc, LLC | 2024-08-27 |
| K240605 | Ultra RapidWarm Blast | Vitrolife Sweden AB | 2024-08-07 |
| K233477 | Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) | Shandong Wego Ruisheng Medical Device Co., Ltd. | 2024-07-01 |
| K240149 | Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-06-13 |
| K234023 | Oocyte Flushing & Retrieval Medium; Gamete Buffer | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-05-10 |
| K233764 | SSS-NX (Serum Substitute Supplement-NX) | Fujifilm Irvine Scientific | 2024-04-24 |
| K232125 | V-PVP | Vitromed GmbH | 2024-03-20 |
| K232942 | G-Vitri Vitrification Freeze Media; G-Vitri Vitrification Thawing Media | Gimbo Medical Technology Shenzhen Co., Ltd. | 2024-01-30 |
| K231370 | Dewin Blastocyst Medium (with HSA and without HSA) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2023-08-04 |
| K222606 | V-HYADASE | Vitromed GmbH | 2023-05-26 |
| K223265 | CryoX Vitrification Freeze Kit / Thaw Kit | Zhejiang Horizon Medical Technology Co., Ltd. | 2023-05-11 |
| K220715 | ARTSMedia In Vitro Culture Medium (AM-IVC Medium) | Artsmedia Denmark Aps | 2023-02-10 |
| K223117 | V-SPERM WASH | Vitromed GmbH | 2023-01-31 |
| K213293 | V-HEPES PLUS | Vitromed Langenfeld | 2022-09-14 |
| K212426 | Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2022-06-16 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 60888937029798 | ORIGIO Gradient 90 w/o Gentamicin | Coopersurgical, Inc. | 2026-03-12 |
| 00859500005325 | FemSperm No Analysis | FEMASYS INC. | 2026-02-06 |
| 00859500005356 | FemSperm No Analysis | FEMASYS INC. | 2026-02-06 |
| 60888937029200 | MC Vitrification Warming | Coopersurgical, Inc. | 2026-02-05 |
| 60888937029194 | MC Vitrification Cooling | Coopersurgical, Inc. | 2026-02-05 |
| 60888937028203 | IVM System | Coopersurgical, Inc. | 2026-02-05 |
| 00888937029970 | ICSI Cumulase | Coopersurgical, Inc. | 2026-02-05 |
| 00888937027921 | SynVitro Hyadase | Coopersurgical, Inc. | 2026-02-05 |
| 00888937833041 | SAGE 1-Step | Coopersurgical, Inc. | 2026-02-05 |
| 00888937029383 | ORIGIO Gradient 90 | Coopersurgical, Inc. | 2026-02-05 |
| 60888937029361 | ORIGIO Gradient 100 | Coopersurgical, Inc. | 2026-02-05 |
| 60888937029330 | ORIGIO Sperm Wash | Coopersurgical, Inc. | 2026-02-05 |
| 00888937029123 | SAGE 1-Step | Coopersurgical, Inc. | 2026-02-05 |
| 00888937029116 | SAGE 1-Step | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028980 | Origio Handling | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028973 | Origio Handling | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028966 | Origio Handling | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028959 | Origio Handling | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028607 | SynVitro Flush | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028461 | ORIGIO Sequential Fert | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028454 | ORIGIO Sequential Fert | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028447 | ORIGIO Sequential Fert | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028430 | ORIGIO Sequential Fert | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028416 | ORIGIO Sequential Cleav | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028409 | ORIGIO Sequential Cleav | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028393 | ORIGIO Sequential Cleav | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028386 | ORIGIO Sequential Cleav | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028355 | ORIGIO Sequential Blast | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028348 | ORIGIO Sequential Blast | Coopersurgical, Inc. | 2026-02-05 |
| 00888937028331 | ORIGIO Sequential Blast | Coopersurgical, Inc. | 2026-02-05 |