AccessGUDID - DEVICE: INT (06950900965326)

GUDID

Device Identifier (DI) Information

Brand Name: INT
Version or Model: YCK100F
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shanghai Kindly Medical Instruments Co., Ltd.

Primary DI Number: 06950900965326
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 420827639 *Terms of Use

Device Description: Push-Rotate Y connector with 15 cm extension tube,45 psi stopcock, torque device, insertion tool;

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?
65480	Vascular guidewire introduction sleeve	A noninvasive tubular device designed to be connected to the proximal (external) end of an in situ vascular introducer or guide catheter, and inserted beyond the pre-opened haemostatic valve, to facilitate introduction of a vascular guidewire. It is intended to channel the guidewire to prevent bending/kinking as forward pressure is applied. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170024	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: 51143fa8-68e9-43eb-a9df-f342d5df2561
Public Version Date: August 22, 2023
Public Version Number: 1
DI Record Publish Date: August 14, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
16950900965323	25	06950900965326	In Commercial Distribution	box
56950900965321	100	06950900965326	In Commercial Distribution	carton
26950900965320	50	06950900965326	In Commercial Distribution	box
46950900965324	200	06950900965326	In Commercial Distribution	carton