Product code IMD

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
Pack, Hot Or Cold, Disposable
Medical specialty
Physical Medicine
Device class
1
Regulation number
890.5710
Review panel
PM
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)DeviceApplicantDecision date
K221653InfaTherm Disposable Infant Warming MattressInternational Biomedical2022-10-06
K163295Infant Transport Mattress Warmer with DiscRapid Aid Corp.2017-07-24
K112547NEO NESTDenovo Proucts, LLC2012-03-06
K082087EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.2008-09-11
K071710BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS)Johnson & Johnson Consumer Products, Inc.2007-08-14
K021843EYEFEEL OPHTHALMIC WARMERBio-Lipid, Inc.2002-09-03
K982652ALLEGIANCE PORTA-WARM MATTRESSAllegiance Healthcare Corp.1999-01-21
K980509DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESSDeroyal Industries, Inc.1998-02-26
K974190CP&S INSTANT COLD PACK LIMB KIT TRANSPORTERConsolidated Products & Services, Inc.1997-11-19
K973770ALLEGIANCE KWIK HEAT WARM PERINEAL PACKAllegiance Healthcare Corp.1997-11-13
K970399KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD)Allegiance Healthcare Corp.1997-04-03
K963689RECOVER ADULT VEIN WARMERFlorida Medical Industries, Inc.1996-12-12
K963768INSTANT HOT PACKSKick Ice, Inc.1996-11-25
K963666INSTANT COLD PACKKick Ice, Inc.1996-10-30
K963220TEMPRA COLD PACK, REORDER NO. TC150Tempo Technology, Inc.1996-10-10
K961176OMNI COLD GEL PACKSOmni Therm, Inc.1996-09-04
K955788IMNI HOT PACKSOmni Therm, Inc.1996-09-04
K951033ANDELA DYNAMIC COOLING DEVICECandela Laser Corp.1996-08-15
K960624CERTI COOL INSTANT COLD COMPRESSCertified Safety Mfg., Inc.1996-05-06
K954877OMNI COLD GEL PACKSOmni Therm, Inc.1996-02-13
K953442RESTORE, THERMACELLS (HOT PACK I)Neal Dunning Assoc., Inc.1995-10-31
K953542COLDGELPrism Technologies, Inc.1995-10-30
K953541INSTANT COLDGELPrism Technologies, Inc.1995-10-05
K950680INFANT HEEL WARMERBaxter Healthcare Corp1995-08-23
K951383TEMPRA HEAT PACKTempra Technology, Inc.1995-06-01
K941245POLY-MEDICS HEAT PACKBiomet, Inc.1994-05-02
K936084OMNI WARM GEL PACKSOmni Therm, Inc.1994-03-31
K940336CERTI HEAT INSTANT HEAT COMPRESSCertified Safety Mfg., Inc.1994-03-07
K935569INSTANT HOT OR COLD DISPOSABLE PACKCryopak Industries, Inc.1994-03-07
K934631TRANSWARMERPrism Technologies, Inc.1994-02-03

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