AccessGUDID - DEVICE: CONMED (30653405014977)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 9036290
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9036290
Company Name: Conmed Corporation

Primary DI Number: 30653405014977
Issuing Agency: GS1
Commercial Distribution End Date: December 05, 2023
Device Count: 60
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: SUCTION CONNECTING TUBING WITH CONNECTORS, 10' LONG (3M), 1/4" I.D. (6.4MM)

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?
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
BYY	TUBE, ASPIRATING, FLEXIBLE, CONNECTING

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 6.4 Millimeter
Lumen/Inner Diameter: .25 Inch
Length: 10 Feet
Length: 3 Meter

Device Record Status

Public Device Record Key: 31e515b2-54a2-4c28-9398-d2f3c9fc2ab6
Public Version Date: August 21, 2024
Public Version Number: 7
DI Record Publish Date: September 24, 2016