AccessGUDID - DEVICE: CORE DYNAMICS (10653405045472)

GUDID

Device Identifier (DI) Information

Brand Name: CORE DYNAMICS
Version or Model: CD3005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CD3005
Company Name: Conmed Corporation

Primary DI Number: 10653405045472
Issuing Agency: GS1
Commercial Distribution End Date: June 08, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: Insufflation Tubing With 0.2 Micron Filter, 10 Foot Length

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?
38559	Insufflation gas conditioning tubing set	A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HES	INSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES)

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 3 Meter
Length: 10 Feet
Device Size Text, specify: Filter

Device Record Status

Public Device Record Key: 5523bb69-02c9-4e04-acf1-c48b28753652
Public Version Date: June 09, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016