FDA.reportPublic FDA data

CODA

Primary DI
05060554120024
Brand
CODA
Company
RESEARCH INSTRUMENTS LIMITED
Model
K59549 Coda Inline Filter for G185 US
Catalog number
K59549
Device description
The Coda Air Purification System will be used as an accessory item during assisted reproductive procedures
Published
2024-09-20
Public version status
New
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060554120024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060554120024050605541200245060554120024

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
536139413
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060170181454EZ-Tip125 micron tip id7-72-2125/52017-12-22
05060170181461EZ-Tip135 micron tip id7-72-2135/52017-12-22
05060170181478EZ-Tip145 micron tip id7-72-2145/52017-12-22
05060170181485EZ-Tip155 micron tip id7-72-2155/52017-12-22
05060170181492EZ-Tip170 micron tip id7-72-2170/52017-12-22
05060170181508EZ-Tip200 micron tip id7-72-2200/52017-12-22
05060170181515EZ-Tip290 micron tip id7-72-2290/52017-12-22
05060170181522EZ-Tip600 micron tip id7-72-2600/52017-12-22
05060170181539EZ-Tip125 micron tip id7-72-4125/202017-12-22
05060170181546EZ-Tip135 micron tip id7-72-4135/202017-12-22
05060170181553EZ-Tip145 micron tip id7-72-4145/202017-12-22
05060170181560EZ-Tip155 micron tip id7-72-4155/202017-12-22
05060170181577EZ-Tip170 micron tip id7-72-4170/202017-12-22
05060170181591EZ-Tip200 micron tip id7-72-4200/202017-12-22
05060170181607EZ-Tip290 micron tip id7-72-4290/202017-12-22
05060170181614EZ-Tip600 micron tip id7-72-4600/202017-12-22
05060170181690EZ-GripEZ-Grip7-72-28002017-12-22
05060170183328EZ-Tip75 micron tip id7-72-2075/52017-12-22
05060170183380EZ-GripEZ-Grip with Comfort Rest7-72-28022017-12-22
05060170183441EZ-Tip75 micron tip id7-72-4075/202017-12-22

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
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
03661532000516STERILE 0.3 ML CBS STRAW WITH WHITE JACKET AND GREEN FLEXIBLE ROD / BLISTER 5X15CRYO BIO SYSTEMMQG2020-11-03