AccessGUDID - DEVICE: Suction Connection Tube (06971092637679)

GUDID

Device Identifier (DI) Information

Brand Name: Suction Connection Tube
Version or Model: Type I, 3000mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: YDSI3000
Company Name: Shijiazhuang Yuanding Medical Device Co., LTD

Primary DI Number: 06971092637679
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 80
Labeler D-U-N-S® Number*: 560446074 *Terms of Use

Device Description: Suction connection tube, Type I, 3000mm

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?
16779	Suction/irrigation tubing, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOL	Catheter And Tip, Suction

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
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 3000 Millimeter

Device Record Status

Public Device Record Key: 9fffd408-0076-4662-904b-0de6781b81f7
Public Version Date: October 23, 2024
Public Version Number: 2
DI Record Publish Date: March 06, 2024