FDA UDI
In Commercial Distribution
🇺🇸 United States
Medic
DI: 04719875322082
·
Model: M-OA-FH01
·
MEDIC TRADE CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Medic
- Primary DI
- 04719875322082
- Version / Model
- M-OA-FH01
- Company Name
- MEDIC TRADE CO., LTD.
- Labeler DUNS
- 656820797
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-30
- Public Version
- 2
- Public Version Date
- 2023-06-02
- Public Version Status
- Update
- Public Device Record Key
- 9f1e9f6b-da6e-4932-a378-67a2e24f7397
Device Description
The Expiratory Filter Heater is designed to warm the surface of a filter used in the expiratory pathway of a breathing circuit. The device is intended to prolong filter efficiency by minimizing excessive condensation that can cause expiratory resistance. Adding a heated filtration system to a ventilator can also protect the exhalation system and currounding environment from contamination which prevents the spread of infectious diseases. The heater consists of an aluminum heating surface that is thermostatically controlled to maintain an ideal temperature.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IRQ | Unit, Heating, Powered | Physical Medicine | 890.5950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61736 | Breathing circuit condenser | A portable, mains electricity (AC-powered) device designed to be integrated within the expiratory limb of a ventilator breathing circuit to remove excess moisture through cooling and condensing, whilst also reheating the dried gases to an appropriate ventilator-compatible temperature. It includes a heat exchanger and may include disposable condensate collection devices (e.g., cartridge, collection bag). It is intended to prevent condensation from forming within the expiratory limb and ventilator (rain-out). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719875322082 | GS1 | ||||
| Package | 14719875322089 | GS1 | 1 | In Commercial Distribution | ||
| Package | 24719875322086 | GS1 | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 3602324119
- [email protected]