FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS-Heat Moisture Exchanger-Air
DI: 08904461000499
·
Model: EA91001
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OSSEOUS-Heat Moisture Exchanger-Air
- Primary DI
- 08904461000499
- Version / Model
- EA91001
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-03-13
- Public Version
- 1
- Public Version Date
- 2026-03-23
- Public Version Status
- New
- Public Device Record Key
- 192fe80c-f9a1-463a-878b-a042f31a5a3f
Device Description
The HMEs traps heat and moisture from exhaled air and makes inhaled air more humid and warmer to reduce mucus generation and irritation in wind pipe to make patient comfortable. It is artificial nose for laryngectomy patient. It comes in different level of humidification, breathing Resistance and filtration that makes to use in different situations.
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | Anesthesiology | 868.5375 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35530 | Heat/moisture exchanger, single-use | A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08906039318012 | GS1 | Laminated Box | 30 | In Commercial Distribution | |
| Primary | 08904461000499 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 25 – Degrees Celsius