FDA UDI
In Commercial Distribution
🇺🇸 United States
VADI
DI: 04719875347023
·
Model: VH-210
·
VADI MEDICAL TECHNOLOGY CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VADI
- Primary DI
- 04719875347023
- Version / Model
- VH-210
- Catalog Number
- 800-21101-UL
- Company Name
- VADI MEDICAL TECHNOLOGY CO., LTD.
- Labeler DUNS
- 657254280
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-20
- Public Version
- 2
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- c3cb0813-dbb7-4d94-8959-f6b5790c6fda
Device Description
Bacteria filter heater
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRQ | Unit, Heating, Powered | Physical Medicine | 890.5950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36364 | Bottle warmer | A mains electricity (AC-powered) heating device into which a bottle is intended to be placed for the preheating of its contents (e.g., milk for feeding infants, water, or other fluids). It typically consists of a tabletop device that has a well(s) for placement of the bottle(s), a heating element, a thermostat, and operating controls. It is designed to be portable for use in different locations. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14719875347020 | GS1 | carton | 6 | In Commercial Distribution | |
| Primary | 04719875347023 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | AC 100-120V |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 65 Degrees Celsius