AccessGUDID - DEVICE: Esperance 3+ Aspiration Catheter System (06970908212932)

GUDID

Device Identifier (DI) Information

Brand Name: Esperance 3+ Aspiration Catheter System
Version or Model: ASP3F160KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shanghai Wallaby Medical Technologies Co., Inc.

Primary DI Number: 06970908212932
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544535295 *Terms of Use

Device Description: The Esperance® 3+ Aspiration Catheter is a single-use, vascular catheter consisting of a single lumen, variable stiffness, composite catheter.

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):	No
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?
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRY	Catheter, Thrombus Retriever

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240917	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e64107a8-dcfa-4241-8975-a6d951bd828f
Public Version Date: November 19, 2024
Public Version Number: 1
DI Record Publish Date: November 11, 2024