AccessGUDID - DEVICE: Centurion (00653160230246)

GUDID

Device Identifier (DI) Information

Brand Name: Centurion
Version or Model: DT13725
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DT13725
Company Name: CENTURION MEDICAL PRODUCTS CORPORATION

Primary DI Number: 00653160230246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017246562 *Terms of Use

Device Description: ON/OFF KITS

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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?
32142	Haemodialysis start/stop set	A collection of instruments and associated items used for the start and/or stop procedures (also known as ON and OFF procedures) for a patient undergoing haemodialysis. It typically includes items such as syringes, needles, dressings, swabs, forceps, and protective wear for the healthcare provider such as gloves, face mask, and a gown. This device is used for the connection session and/or the disconnection session where the patient is connected/disconnected to the haemodialysis system. It does not include pharmaceuticals and typically does not include catheters. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FKG	TRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: abd1e783-5880-42f9-a15f-0b573a819cc9
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: January 01, 2022