FDA.reportPublic FDA data

MIRI

Primary DI
04779041940106
Brand
MIRI
Company
ESCO MEDICAL TECHNOLOGIES UAB
Model
MIRI
Device description
The incubator is a new generation of desktop CO2 and O2 incubator used for maintaining an optimal environment for the development of Embryos and Blastocysts.
Published
2016-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K133742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133742000XQ-1 INCUBATORAt Medical Uab2014-04-23MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04779041940106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04779041940106047790419401064779041940106

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
365831125
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04779041940144Dish for MIRI TLCultureCoin2026-01-15
04779041940168Multiroom IVF incubatorMini MIRI Dry2026-01-15
04779041940199Multiroom IVF incubatorMini MIRI Humidity2026-01-15
04779041940212Multiroom IVF incubatorMIRI2026-01-15
04779041940229Multiroom IVF incubatorMIRI2026-01-15
04779041940267Multiroom IVF incubatorMIRI II-122026-01-15
04779041940311MIRI Time-Lapse IncubatorMIRI TL122026-01-15
04779041940809Multiroom IVF incubatorMIRI M Chamber2026-01-15
04779041940816Multiroom IVF incubatorMIRI M Docking Station2026-01-15
04779041940113MIRI TLMIRI TL2016-10-13
04779041940243Multiroom IVF incubatorMIRI Humidity2026-01-14
04779041940298MIRI Time-Lapse IncubatorMIRI TL62026-01-14
04779041940465Multi-zone ART WorkstationMAW-4D2026-01-14
04779041940472Multi-zone ART WorkstationMAW-3D2026-01-14
04779041940496Multi-zone ART WorkstationMAW-6D2026-01-14
04779041940502Multi-zone ART WorkstationMAW-6D2026-01-14
04779041940519Multi-zone ART WorkstationMAW-6D-DUAL2026-01-14
04779041940526Multi-zone ART WorkstationMAW-6D-DUAL2026-01-14
04779041940533Multi-zone ART WorkstationMAW-6D-DUAL2026-01-14
04779041940540Multi-zone ART WorkstationMAW-6D-MP2026-01-14

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