AccessGUDID - DEVICE: CORE DYNAMICS (10653405046585)

GUDID

Device Identifier (DI) Information

Brand Name: CORE DYNAMICS
Version or Model: CD983A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CD983A
Company Name: Conmed Corporation

Primary DI Number: 10653405046585
Issuing Agency: GS1
Commercial Distribution End Date: November 27, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: Ohmeda Quick Connect Coupler

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:	No
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?
38468	Intravenous pressure infusor, automated	A pneumatically-powered device designed to increase the rate of an intravenous (IV) infusion given to a patient by applying pressure directly to the infusion bag. The device is designed with a pressure chamber into which the infusion bag is secured, and is connected to a supply of pressurized air which, when activated, creates pressure in the rear of the chamber. It typically includes a pressure gauge to indicate the applied pressure and overpressure safety features.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.125 Inch

Device Record Status

Public Device Record Key: e2e1879e-8de3-4ec1-8168-e1e5e6712385
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016