AccessGUDID - DEVICE: Centurion (00653160234879)

GUDID

Device Identifier (DI) Information

Brand Name: Centurion
Version or Model: SB0250ST
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SB0250ST
Company Name: CENTURION MEDICAL PRODUCTS CORPORATION

Primary DI Number: 00653160234879
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017246562 *Terms of Use

Device Description: STERILE PT BOWL

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:	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?
42871	Emesis bowl, single-use	A device designed as a receptacle for vomit or oral secretions, typically from an immobile patient (e.g., one confined to bed, chair, or wheelchair). It is typically shallow and kidney-shaped, and therefore commonly known as a kidney bowl or basin. It is typically made of disposable plastic materials, and is discarded with its waste contents. The device is also commonly used to hold and transport medical/surgical materials or instruments for a procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNY	BASIN, EMESIS

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: 8d9bc4a6-63ba-48fd-bfd5-5e1ac4dc3bdb
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: January 02, 2022