FDA.reportPublic FDA data

Cook

Primary DI
00827002492752
Brand
Cook
Company
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Model
G49275
Catalog number
K-MAR-5200
Device description
Vacuum Pump
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
K160753000
K992070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160753000COOK Vacuum PumpWilliam A. Cook Australia Pty. , Ltd.2017-06-13MQG
K992070000COOK ULTRA QUIET VACUUM PUMP & REGULATORCook Urological, Inc.1999-10-27MQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002492752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002492752008270024927528270024927520827002492752

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose suction system, line-poweredAn assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of settings within healthcare facilities.

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
00827002341753CookG34175K-DOPU-1735-T-A-602016-09-24
00827002341869CookG34186K-DOPU-1735-T-A-902016-09-24
00827002384279CookG38427K-OSN-1630-B-60-US2016-09-24
00827002384286CookG38428K-OSN-1630-B-90-US2016-09-24
00827002384309CookG38430K-OSN-1635-B-90-US2016-09-24
00827002384323CookG38432K-OSN-1725-B-60-US2016-09-24
00827002384330CookG38433K-OSN-1730-B-60-US2016-09-24
00827002388451CookG38845K-OPS-7035-RWH-ET-US2016-09-24
00827002443556CookG44355K-OPAA-1735-US2016-09-24
00827002443600CookG44360K-OPS-2130-US2016-09-24
00827002552487CookG55248K-OPS-1635-H-B-902016-09-24
00827002552517CookG55251K-OPS-1728-T-A-602016-09-24
00827002552524CookG55252K-OPS-1735-T-A-902016-09-24
00827002554788CookG55478K-OSN-1635-R-B-902016-09-24
00827002554801CookG55480K-OSN-1633-R-B-902016-09-24
00827002554832CookG55483K-OPS-1630-H-B-602016-09-24
00827002554870CookG55487K-OPS-1635-T-A-902016-09-24
00827002554900CookG55490K-OPS-1735-T-A-602016-09-24
00827002554917CookG55491K-OPS-1733-T-A-602016-09-24
00827002554931CookG55493K-OPS-1730-R-B-602016-09-24

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