AccessGUDID - DEVICE: Connector for silicone Fr 10-12 (08034139297019)

GUDID

Device Identifier (DI) Information

Brand Name: Connector for silicone Fr 10-12
Version or Model: 10523
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10523
Company Name: REDAX SPA

Primary DI Number: 08034139297019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338664915 *Terms of Use

Device Description: Fittinig device designed to facilitate the connection of the tubes/drainage catheters.

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?
45389	Closed-wound drain connector	A tubular, noninvasive device designed to connect compatible components of a closed-wound drainage kit (e.g., the drain tubing to the drain bag or reservoir); it is not intended to connect components of suction systems (e.g., not used in general surgery). It will typically be shaped as a straight bore connector or a Y-piece connector. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCD	Connector, Catheter

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d13f7f0b-97e2-4ca1-913f-c7823cb929bf
Public Version Date: May 19, 2021
Public Version Number: 1
DI Record Publish Date: May 11, 2021