AccessGUDID - DEVICE: NOVO Health Services, LLC (00812564032720)

GUDID

Device Identifier (DI) Information

Brand Name: NOVO Health Services, LLC
Version or Model: 124122
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 124122
Company Name: NOVO HEALTH SERVICES, LLC

Primary DI Number: 00812564032720
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069936106 *Terms of Use

Device Description: Bowl, Eye 900cc

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?
11522	Emesis bowl, reusable	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 high-grade stainless steel or durable plastic materials, and is also commonly used to hold and transport medical/surgical materials or instruments for a procedure. This is a reusable 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: 01cf0c87-21fc-4522-a8ba-cebd1d45b694
Public Version Date: March 09, 2020
Public Version Number: 2
DI Record Publish Date: October 05, 2018