AccessGUDID - DEVICE: Codonics Safe Label System® Administration Tool (00814905020038)

GUDID

Device Identifier (DI) Information

Brand Name: Codonics Safe Label System® Administration Tool
Version or Model: 2.1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CODONICS INC.

Primary DI Number: 00814905020038
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 101533727 *Terms of Use

Device Description: V2.1.0 Administration Tool compatible with Codonics Safe Label System® 500i Point of Care Station

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?
18169	Parenteral-nutrition management software	A software program intended to facilitate the management of the ordering, calculation, and preparation of customizable parenteral nutrition dosages for individual patients, according to physician prescriptions. It is used in conjunction with filling and compounding machines in hospital pharmacies and compounding centres to enable the automated and systematic production of parenteral nutrition dosages.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BSZ	Gas-Machine, Anesthesia

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101439	000

Device Exempt from Premarket Submission: No 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
No Device Sizes

Device Record Status

Public Device Record Key: 2ab812f0-c7a1-4e39-beb4-247bc993372a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 23, 2016