AccessGUDID - DEVICE: Ceodeux S.A - Meditec (05400992008360)

GUDID

Device Identifier (DI) Information

Brand Name: Ceodeux S.A - Meditec
Version or Model: M98600002 (old number) - 1106138 (new SAP number)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M986
Company Name: CEODEUX S.A.

Primary DI Number: 05400992008360
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 400635868 *Terms of Use

Device Description: No description.

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):	No
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?
58754	Nitric oxide refillable cylinder	A container designed as a refillable cylinder used to hold compressed nitric oxide (NO), also known as nitrogen monoxide, under safe conditions at high pressure. It is typically filled with NO when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote NO content. The cylinder is made of non-corrosive aluminium (Al) and must be used with a pressure regulator in order to release the NO at the correct working pressure. NO is used for severe respiratory problems in neonates, children, and adults, e.g., for treatment of primary pulmonary hypertension (PPH) and some surgical interventions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECX	Cylinder, Compressed Gas, And Valve

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
No Device Sizes

Device Record Status

Public Device Record Key: 0ae1a685-747c-4f43-8199-1d73e86c6d9b
Public Version Date: November 15, 2023
Public Version Number: 1
DI Record Publish Date: November 07, 2023