FDA UDI
In Commercial Distribution
🇺🇸 United States
TECME
DI: 14897132250471
·
Model: VHB20
·
VINCENT HEALTHCARE PRODUCTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- TECME
- Primary DI
- 14897132250471
- Version / Model
- VHB20
- Catalog Number
- 50011072
- Company Name
- VINCENT HEALTHCARE PRODUCTS LIMITED
- Labeler DUNS
- 664763919
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-17
- Public Version
- 1
- Public Version Date
- 2026-03-25
- Public Version Status
- New
- Public Device Record Key
- 30bd8487-477a-4438-aead-f6b2782bf4c8
Device Description
VHB20 Heated Humidifier\1sets/box
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | Anesthesiology | 868.5450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12050 | Heated respiratory humidifier | A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 64897132250476 | GS1 | case | 1 | In Commercial Distribution | |
| Primary | 14897132250471 | GS1 | ||||
| Direct Marking | 04897132250474 | GS1 |