FDA UDI
In Commercial Distribution
🇺🇸 United States
XTREME
DI: 00805106849603
·
Model: CXN1-7000-WM1
·
Xtreme Personal Care Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- XTREME
- Primary DI
- 00805106849603
- Version / Model
- CXN1-7000-WM1
- Catalog Number
- Nasal Irrigator
- Company Name
- Xtreme Personal Care Inc.
- Labeler DUNS
- 081089201
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-20
- Public Version
- 2
- Public Version Date
- 2025-05-23
- Public Version Status
- Update
- Public Device Record Key
- 93b3644f-356f-41c7-8a53-76a547f425de
Device Description
"Nasal Irrigator with 2 nozzles 1200mA lithium battery cordless use 3 rinse modes for choice waterproof body water tank 200ml"
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| KAR | Irrigator, Sinus | Ear, Nose, Throat | 874.4420 | 1 |
| KMA | Irrigator, Powered Nasal | Ear, Nose, Throat | 874.5550 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48010 | Nasal lavage system | A device assembly designed for automated or semi-automated irrigation and washing of tissue and/or debris from the nose and/or the nasal sinuses. It typically consists of a main electromechanical unit that includes a pump for irrigation/infusion of a jet of non-medicated liquid (e.g., saline); controls for the rate and pressure of irrigation; a reservoir for the solution; and a handpiece that may include a set of detachable tips intended for introduction into the nostrils. The system is used mainly for allergy treatment, nasal congestion, and before and after surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00805106849603 | GS1 |
Customer Contacts
- Phone
- 844-777-9601
- [email protected]