FDA.reportPublic FDA data

Panasonic

Primary DI
04987905300045
Brand
Panasonic
Company
PHC CORPORATION
Model
MCO-170AICUV-PA
Device description
This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K013703000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013703000SANYO CO2 INCUBATORS, MODELS NOS. MCO-17AC, MCO-17AIC, MCO-20AIC,AND MC0-175MSanyo North America Corp.2001-12-14MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987905300045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987905300045049879053000454987905300045

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide laboratory incubatorA mains electricity (AC-powered) incubator in which a fixed temperature and carbon dioxide (CO2) controlled conditions can be achieved and maintained. It is used for the incubation of biological and chemical materials. The percentage mixture of carbon dioxide and other gases, typically oxygen, can be different depending on the use and device type.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
691795268
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987595300011PATHFAST Sample Diluent 1N/A2025-04-18
04987595300028PATHFAST Sample Diluent 2N/A2025-04-18
04987595300646PATHFASTN/A3006462023-06-12
04987595301131PATHFAST cTnI-IIN/A2016-09-22
04987595301230PATHFAST Myo-IIN/A2016-09-22
04987595301339PATHFAST CK-MB-IIN/A2016-09-22
04987595301537PATHFAST D-DimerN/A2016-09-22
04987595301636PATHFAST NTproBNPN/A2016-09-22
04987595301742PATHFAST hsCRPN/A2016-09-22
04987595301803PATHFAST hs-cTnI-IIN/A3018032024-05-01
04987905300236PHCbiMCO-170MG-PA2018-04-25
04987905300199PHCbiMDF-U334-PA2018-04-25
04987905300205PHCbiMDF-U5312-PA2018-04-25
04987905300212PHCbiMCO-5M-PA2018-04-25
04987905300069PanasonicMCO-19M-PA2016-09-24
04987905300076PanasonicMCO-19MUV-PA2016-09-24
04987905300090PanasonicMCO-230AICUV-PA2016-09-24
04987905300113PanasonicMCO-5M-PA2016-09-24
04987905300120PanasonicMCO-170M-PA2016-09-24
04987905300229PHCbiMCO-170M-PA2018-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03661532000363STERILE CBS 0.5 ML STRAW FOR SPERM WITH GREEN COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000370STERILE CBS 0.5 ML STRAW FOR SPERM WITH BLUE COTTON PLUG / 5 X 20CRYO BIO SYSTEMMQG2020-11-03
03661532000479STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND RED FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03
03661532000486STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND WHITE FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03
03661532000493STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND YELLOW FLEXIBLE ROD / BLISTER 5X1CRYO BIO SYSTEMMQG2020-11-03
03661532000509STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND BLUE FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03