Geri Water Bottle

GUDID 09348265003048

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

GENEA BIOMEDX PTY LTD

Sterile solution storage bottle, single-use
Primary Device ID09348265003048
NIH Device Record Key2b042c3b-18fd-44f4-a1ad-18968c6b29ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeri Water Bottle
Version Model NumberGERI-WAT-01
Company DUNS752103403
Company NameGENEA BIOMEDX PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348265003048 [Primary]
GS119348265003045 [Package]
Package: [12 Units]
In Commercial Distribution
GS129348265003042 [Package]
Contains: 19348265003045
Package: [24 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQKLabware, Assisted Reproduction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2018-05-04

Devices Manufactured by GENEA BIOMEDX PTY LTD

29348265003011 - Geri Dish2021-03-10 The Geri Dish is intended to be used for preparation, storage and imaging of human embryos. The Geri Dish is intended to be used
09348265003048 - Geri Water Bottle2019-10-23The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material.
09348265003048 - Geri Water Bottle2019-10-23 The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material.
09348265003024 - Geri Connect Server (including software)2019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m
09348265003079 - Geri Software Connect and Assess 1.32019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m
09348265003086 - Geri Software Connect and Assess 2.02019-04-23 Geri Connect & Geri Assess connects one or more Geri incubators through a LAN. The Geri Connect & Geri Assess software enables m

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