AccessGUDID - DEVICE: Y-type Irrigation Set (06974880990697)

GUDID

Device Identifier (DI) Information

Brand Name: Y-type Irrigation Set
Version or Model: 5mm×7mm×600mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Suzhou AcuVu medical technology Co., Ltd.

Primary DI Number: 06974880990697
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 705464292 *Terms of Use

Device Description: It is used to connect the water inlet and outlet of the hysteroscope for circulating perfusion.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
63460	Fluid transfer tube, general-purpose	A sterile, flexible, blunt tubular device made of plastic materials designed to be used for the manual transfer of several types of medical fluids (e.g., solutions, syrups) between a first container (e.g., a vial) and a second container [e.g., a syringe]; it is not dedicated to a particular type of fluid or clinical procedure. It is not intended to puncture the seal of a vial/container, nor is it intended for patient contact. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWW	Hysteroscope Accessories

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 283055e2-264e-4696-8f50-ee5663b74b9a
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023