FDA.reportPublic FDA data

JETi™

Primary DI
08717648351372
Brand
JETi™
Company
ABBOTT VASCULAR INC.
Model
WVCART
Catalog number
WVCART
Device description
JETi™ Accessory Cart
Published
2021-12-08
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
FOXStand, Infusion
QEZAspiration Thrombectomy Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1
QEZAspiration Thrombectomy CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201998000JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC2020-11-17QEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B139WVCART0PreviousHIBCC0
08717648351372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648351372087176483513728717648351372

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius60 Degrees Celsius
Special Storage Condition, Specify00Store in a dry place between 15°C – 25°C (59°F – 77°F) with excursions permitted.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-9902AV.CUSTOMERCARE@AV.ABBOTT.COM

Regulatory Flags#

DUNS number
964569052
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717648175060StarClose SE™ 14679-0514679-052014-11-21
08717648000621Prostar™ 12322-0112322-012014-11-21
08717648199059XIENCE ALPINE1125225-081125225-082014-11-21
08717648199066XIENCE ALPINE1125225-121125225-122014-11-21
08717648199073XIENCE ALPINE1125225-151125225-152014-11-21
08717648199080XIENCE ALPINE1125225-181125225-182014-11-21
08717648199097XIENCE ALPINE1125225-231125225-232014-11-21
08717648199103XIENCE ALPINE1125225-281125225-282014-11-21
08717648199141XIENCE ALPINE1125250-081125250-082014-11-21
08717648199158XIENCE ALPINE1125250-121125250-122014-11-21
08717648199165XIENCE ALPINE1125250-151125250-152014-11-21
08717648199172XIENCE ALPINE1125250-181125250-182014-11-21
08717648199189XIENCE ALPINE1125250-231125250-232014-11-21
08717648199196XIENCE ALPINE1125250-281125250-282014-11-21
08717648199202XIENCE ALPINE1125250-331125250-332014-11-21
08717648199219XIENCE ALPINE1125250-381125250-382014-11-21
08717648199233XIENCE ALPINE1125275-081125275-082014-11-21
08717648199240XIENCE ALPINE1125275-121125275-122014-11-21
08717648199257XIENCE ALPINE1125275-151125275-152014-11-21
08717648199264XIENCE ALPINE1125275-181125275-182014-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050863483AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-06-08
00840117346307Vital Signs Stand, Compatible with item 10843Dynarex CorporationFOX2026-06-08
00761887005471PryorPRYOR PRODUCTSFOX2026-05-31
04061162002116CIM med GmbHCIM med GmbHFOX2026-05-31
04061162051893CIM med GmbHCIM med GmbHFOX2026-05-31
00885403530145TRUCLIPBecton, Dickinson And CompanyFOX2026-05-30
00840432200056Verathon®Verathon Medical (Canada) ULCFOX2026-05-28
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00761887005464PryorPRYOR PRODUCTSFOX2026-05-26
00810050863469AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00810050863476AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00761887005419PryorPRYOR PRODUCTSFOX2026-05-25
00761887005433PryorPRYOR PRODUCTSFOX2026-05-25
00761887005440Connected RockPRYOR PRODUCTSFOX2026-05-25
00761887005457CorCytePRYOR PRODUCTSFOX2026-05-25
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00763000998011Liberant™MEDTRONIC, INC.QEZ2026-05-09
00810050863414Pole MountLIFEPORT, LLCFOX2026-04-28
00810050863421Pole MountLIFEPORT, LLCFOX2026-04-28
B458205997000HVP CartThe Wells Johnson CompanyFOX2026-04-20
B458205998000Wells Johnson Hymen CartThe Wells Johnson CompanyFOX2026-04-20
00810050863407Load RampLIFEPORT, LLCFOX2026-04-17
09420012405890Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012409690Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012416728Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
00810050863391Medical CabinetLIFEPORT, LLCFOX2026-04-07
10841156110505PRONTOTELEFLEX INCORPORATEDQEZ2026-03-30