AccessGUDID - DEVICE: Geri Water Bottle (09348265003048)

GUDID

Device Identifier (DI) Information

Brand Name: Geri Water Bottle
Version or Model: GERI-WAT-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GENEA BIOMEDX PTY LTD

Primary DI Number: 09348265003048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 752103403 *Terms of Use

Device Description: The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material.

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?
44643	Intravenous/irrigation solution storage container, single-use	An empty glass or plastic receptacle intended for the safe storage and easy handling of solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQK	Labware, Assisted Reproduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180304	000

Device Exempt from Premarket Submission: No 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: 2b042c3b-18fd-44f4-a1ad-18968c6b29ee
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: May 04, 2018