AccessGUDID - DEVICE: JETi Pump Set (B139WV00090)

GUDID

Device Identifier (DI) Information

Brand Name: JETi Pump Set
Version or Model: WV0009
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: WV0009
Company Name: WALK VASCULAR L.L.C.

Primary DI Number: B139WV00090
Issuing Agency: HIBCC
Commercial Distribution End Date: November 07, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 034774488 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47625	Surgical irrigation/aspiration tubing set	A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXE	Catheter, Embolectomy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 607 and 810 Millimeter of Mercury
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 13 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5cc0aa47-b245-4fe5-bafd-c61b95761d3b
Public Version Date: September 27, 2022
Public Version Number: 4
DI Record Publish Date: January 24, 2018