FDA.reportPublic FDA data

Thermo Scientific Forma

Primary DI
10815773020097
Brand
Thermo Scientific Forma
Company
THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC
Model
3111
Catalog number
3111
Device description
Water Jacketed CO2 Incubator
Published
2016-09-22
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
K991408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991408000FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATORThermoquest Corp.1999-07-19MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815773020097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081577302009710815773020097

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Indoor use only

Contacts#

Phone, Email table
PhoneEmail
1-800-438-4851service.led.marietta@thermofisher.com

Regulatory Flags#

DUNS number
791530061
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815773020458Thermo Scientific ™ CryoMed™TSCM17CATSCM17CA2021-10-12
00815773020465Thermo Scientific ™ CryoMed™TSCM34CATSCM34CA2021-10-12
00815773020472Thermo Scientific ™ CryoMed™TSCM48CATSCM48CA2021-10-12
00815773020489Thermo Scientific ™ CryoMed™TSCM17TATSCM17TA2021-10-12
00815773020496Thermo Scientific ™ CryoMed™TSCM34TATSCM34TA2021-10-12
00815773020502Thermo Scientific ™ CryoMed™TSCM48TATSCM48TA2021-10-12
00815773020274Thermo Scientific ™ CryoMed™TSCM17MATSCM17MA2021-01-05
00815773020335Thermo Scientific ™ CryoMed™TSCM17MVTSCM17MV2021-01-05
00815773020359Thermo Scientific ™ CryoMed™TSCM34MVTSCM34MV2021-01-05
00815773020373Thermo Scientific ™ CryoMed™TSCM48MVTSCM48MV2021-01-05
00815773020397Thermo Scientific ™ CryoMed™TSCM17EVTSCM17EV2021-01-05
00815773020410Thermo Scientific ™ CryoMed™TSCM34EVTSCM34EV2021-01-05
00815773020434Thermo Scientific ™ CryoMed™TSCM48EVTSCM48EV2021-01-05
00815773020281Thermo Scientific ™ CryoMed™TSCM34MATSCM34MA2021-01-05
00815773020298Thermo Scientific ™ CryoMed™TSCM48MATSCM48MA2021-01-05
00815773020304Thermo Scientific ™ CryoMed™TSCM17EATSCM17EA2021-01-05
00815773020311Thermo Scientific ™ CryoMed™TSCM34EATSCM34EA2021-01-05
00815773020328Thermo Scientific ™ CryoMed™TSCM48EATSCM48EA2021-01-05
00815773020342Thermo Scientific ™ CryoMed™TSCM17MLTSCM17ML2021-01-05
00815773020366Thermo Scientific ™ CryoMed™TSCM34MLTSCM34ML2021-01-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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