FDA.reportPublic FDA data

Cook

Primary DI
00827002182264
Brand
Cook
Company
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Model
G18226
Catalog number
K-FTH-1012
Device description
Test Tube Heater
Published
2016-09-24
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
K983609000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983609000COOK TEST TUBE HEATERCook Ob/Gyn1998-12-16MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002182264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002182264008270021822648270021822640827002182264

GMDN Terms#

Term, Definition table
TermDefinition
Test tube heaterAn electrically-powered device used in the laboratory to hold and maintain at specific temperatures test tubes containing a fluid specimen (e.g., cell samples). The device typically contains several slots to hold test tubes upright, and its heating element is controlled electronically to reliably maintain a physiological temperature.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
758568000
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002384354CookG38435K-OSN-1735-A-90-US2016-09-24
00827002384361CookG38436K-OSN-1735-B-60-US2016-09-24
00827002384378CookG38437K-OSN-1735-B-90-US2016-09-24
00827002483637CookG48363K-OSN-1730-B-90-US2016-09-24
00827002552531CookG55253K-OSN-1733-R-B-902016-09-24
00827002554764CookG55476K-UCI-1735-R-CTU2016-09-24
00827002554771CookG55477K-OSN-1735-R-B-902016-09-24
00827002557857CookG55785K-OPSD-1630-A-L-US2016-09-24
00827002557864CookG55786K-OPSD-1630-A-S-US2016-09-24
00827002557871CookG55787K-OPSD-1635-A-L-US2016-09-24
00827002557888CookG55788K-OPSD-1635-A-S-US2016-09-24
00827002557895CookG55789K-OPSD-1633-A-S-US2016-09-24
00827002557901CookG55790K-OPSD-1630-B-L-US2016-09-24
00827002557918CookG55791K-OPSD-1630-B-S-US2016-09-24
00827002557925CookG55792K-OPSD-1635-B-S-US2016-09-24
00827002557963CookG55796K-OPSD-1735-A-L-US2016-09-24
00827002557970CookG55797K-OPSD-1735-A-S-US2016-09-24
00827002557987CookG55798K-OPSD-1735-B-S-US2016-09-24
00827002341753CookG34175K-DOPU-1735-T-A-602016-09-24
00827002341869CookG34186K-DOPU-1735-T-A-902016-09-24

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