FDA.reportPublic FDA data

Thermo Scientific

Primary DI
10850684007003
Brand
Thermo Scientific
Company
Thermo Electron LED GmbH
Model
Heracell 150i
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQGAccessory, Assisted Reproduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQGAccessory, Assisted ReproductionObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023465000KENDRO HERACELL 240 INCUBATORKendro Laboratory Products, L.P.2003-03-10MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850684007003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085068400700310850684007003

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction heater/incubatorAn electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.

Contacts#

Phone, Email table
PhoneEmail
828-658-4400marilyn.barry@thermofisher.com

Regulatory Flags#

DUNS number
315329990
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850044310514Thermo ScientificThermo Scientific S2TR IVD-MD750010442026-06-10
10850044310538Thermo ScientificThermo Scientific S2T IVD-MD750010402026-06-10
10850044310545Thermo ScientificThermo Scientific X2T IVD-MD750010422026-06-10
10850044310552Thermo ScientificThermo Scientific X2TR IVD-MD750010472026-06-10
10850044310262Thermo ScientificThermo Scientific MT 17 IVD-MD750025772026-05-21
10850044310279Thermo ScientificThermo Scientific MT 17 IVD-MD750025782026-05-21
10850044310309Thermo ScientificThermo Scientific MT 21 IVD-MD750025802026-05-21
10850044310323Fisher ScientificFisherbrand accuSpin 17-HC750025282026-04-22
10850044310347Fisher ScientificFisherbrand accuSpin 17R-HC750025292026-04-22
10850044310354Fisher ScientificFisherbrand accuSpin 21-HC750025302026-04-22
10850044310422Fisher ScientificFisherbrand accuSpin 21R-HC750025312026-04-22
10850044310224Thermo ScientificThermo Scientific S4T IVD-MD750073322026-04-02
10850044310248Thermo ScientificThermo Scientific X4T IVD-MD750073412026-04-02
10850044310255Thermo ScientificThermo Scientific MT 17 IVD-MD750025762026-03-10
10850044310286Thermo ScientificThermo Scientific MT 17 IVD-MD750025982026-03-10
10850044310293Thermo ScientificThermo Scientific MT 21 IVD-MD750025792026-03-10
10850044310378Thermo ScientificThermo Scientific MTR 17 IVD-MD750025882026-03-10
10850044310392Thermo ScientificThermo Scientific MTR 21 IVD-MD750025912026-03-10
10850044310484Thermo ScientificThermo Scientific MTR 21 IVD-MD750025992026-03-10
10850044310491Thermo ScientificThermo Scientific MTR 17 IVD-MD750025972026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888937032833LifeGlobal® Coda®Coopersurgical, Inc.MQG2026-08-03
00888937032840LifeGlobal® Coda®Coopersurgical, Inc.MQG2026-08-03
00888937032871LifeGlobal® Coda®Coopersurgical, Inc.MQG2026-08-03
00888937032901LifeGlobal® Coda®Coopersurgical, Inc.MQG2026-08-03
00888937032918LifeGlobal® Coda®Coopersurgical, Inc.MQG2026-08-03
00888937033915ORIGIOl®Coopersurgical, Inc.MQG2026-08-03
05712714676123ES serverVitrolife A/SMQG2026-04-16
05712714676222EmbryoViewerVitrolife A/SMQG2026-04-16
04779041940144Dish for MIRI TLESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
04779041940212Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
04779041940229Multiroom IVF incubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-15
04779041940298MIRI Time-Lapse IncubatorESCO MEDICAL TECHNOLOGIES UABMQG2026-01-14
06975183900185Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.MQG2025-09-30
06975183900192Time-lapse Incubator Capacity Expansion ModuleHua Yue Medical Technology Co., Ltd.MQG2025-09-30
05060554120024CODARESEARCH INSTRUMENTS LIMITEDMQG2024-09-20
16975737430110MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
06975737430113MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
06975737430106MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
26975737430001MetiecWuhan Huchuang Union Technology Co., Ltd.MQG2024-05-27
00370275091011FS DispenserForward Science Technologies LLCMQG2024-02-21
05055270911643RocketROCKET MEDICAL PLCMQG2023-11-03
05055270984524RocketROCKET MEDICAL PLCMQG2023-10-31
05055270909060RocketROCKET MEDICAL PLCMQG2023-10-30
05055270909329RocketROCKET MEDICAL PLCMQG2023-10-30
05055270984463RocketROCKET MEDICAL PLCMQG2023-10-30
05055270911582RocketROCKET MEDICAL PLCMQG2023-10-24
00827002444294COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MQG2023-08-15
03661532000318STERILE 0.5 ML CBS STRAW FOR SPERM WITH COTTON PLUG / 4x5CRYO BIO SYSTEMMQG2020-11-03
03661532000349STERILE CBS 0.5 ML STRAW FOR SPERM WITH RED COTTON PLUG / 5 x20CRYO BIO SYSTEMMQG2020-11-03
03661532000356STERILE CBS 0.5 ML STRAW FOR SPERM WITH YELLOW COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03