FDA UDI
In Commercial Distribution
🇺🇸 United States
Hometa
DI: 00850024592070
·
Model: G-G10-1A03
·
Hometa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Hometa
- Primary DI
- 00850024592070
- Version / Model
- G-G10-1A03
- Company Name
- Hometa, Inc.
- Labeler DUNS
- 117613680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-05
- Public Version
- 1
- Public Version Date
- 2020-11-13
- Public Version Status
- New
- Public Device Record Key
- 42912ade-85ba-4c27-9a2a-ea9ee32cd26e
Device Description
Drip Assist
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | General Hospital | 880.2420 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46847 | Intravenous gravity infusion monitor | An electronic device intended to monitor and display the volume and flow rate of intravenous (IV) fluids administration during gravity infusion, providing an alarm (visible/audible) when pre-set limits are exceeded. It is attached directly to the drip chamber of the infusion set and functions by means of a sensor (drop counter) designed to measure the amount of fluid passing through the infusion line and/or by measuring the weight of the fluid container. It includes a display screen, and may record data and be capable of wireless connectivity for data transfer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850024592077 | GS1 | Case | 40 | In Commercial Distribution | |
| Primary | 00850024592070 | GS1 |
Customer Contacts
- Phone
- 5189925044
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150687 | 000 |