AccessGUDID - DEVICE: CONMED (20653405015113)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED
Version or Model: 9037860
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9037860
Company Name: Conmed Corporation

Primary DI Number: 20653405015113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 071595540 *Terms of Use
Previous DI: 30653405015110

Device Description: SUCTION CONNECTING TUBING WITH ONE MALE CONNECTOR AND ONE FEMALE CONNECTOR, 6' LONG (1.8 M), 1/4" I.D. (6.4 MM)

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

Clinically Relevant Size

[?]

Size Type Text
Length: 1.8 Meter
Length: 6 Feet

Device Record Status

Public Device Record Key: 5427a919-4857-437c-9a17-704b55bfc499
Public Version Date: August 14, 2024
Public Version Number: 3
DI Record Publish Date: December 05, 2023