FDA.report

JETi™

Primary DI
08717648353277
Company
ABBOTT VASCULAR INC.
Model
WVHAND
Catalog number
WVHAND
Device description
JETi™ Suction Tubing
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
964569052
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
08717648353277PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
08717648353277PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
QEZAspiration Thrombectomy Catheter2Cardiovascular870.5150NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Device Sizes

No records found.

Storage And Handling

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 and dark place between 15°C – 25°C (59°F – 77°F) with excursions permitted.
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-9902av.customercare@av.abbott.com

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08717648356803XACT™83026-0183026-012025-04-17
08717648356810HI-TORQUE COMMAND™ 106000110600012024-11-21
08717648356827HI-TORQUE COMMAND™ 1060001A1060001A2024-11-21
08717648356834HI-TORQUE COMMAND™106000210600022024-11-21
08717648356841HI-TORQUE COMMAND™ 1060002A1060002A2024-11-21

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08717648351396JETi All In One Sterile Kit - 6FrWALK VASCULAR L.L.C.QEZ2021-12-08
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