Duns Number:752103403
Device Description: The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection moldin The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material.
Catalog Number
-
Brand Name
Geri Water Bottle
Version/Model Number
GERI-WAT-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180304,K180304,K180304
Product Code
MQK
Product Code Name
Labware, Assisted Reproduction
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
Package DI Number
19348265003045
Quantity per Package
12
Contains DI Package
09348265003048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |