FDA UDI
In Commercial Distribution
🇺🇸 United States
Geri Water Bottle
DI: 09348265003048
·
Model: GERI-WAT-01
·
GENEA BIOMEDX PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Geri Water Bottle
- Primary DI
- 09348265003048
- Version / Model
- GERI-WAT-01
- Company Name
- GENEA BIOMEDX PTY LTD
- Labeler DUNS
- 752103403
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-04
- Public Version
- 6
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 2b042c3b-18fd-44f4-a1ad-18968c6b29ee
Device Description
The Geri Water Bottle is a two-piece (base and top) item, manufactured by injection molding in polystyrene material.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQK | Labware, Assisted Reproduction | Obstetrics/Gynecology | 884.6160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09348265003048 | GS1 | ||||
| Package | 19348265003045 | GS1 | 12 | In Commercial Distribution | ||
| Package | 29348265003042 | GS1 | 24 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180304 | 000 |