FDA UDI
In Commercial Distribution
🇺🇸 United States
Airpulse
DI: 00198715785128
·
Model: NBM-6B
·
Dongguan SIMZO Electronic Technology Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Airpulse
- Primary DI
- 00198715785128
- Version / Model
- NBM-6B
- Company Name
- Dongguan SIMZO Electronic Technology Co., Ltd.
- Labeler DUNS
- 544332470
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-02
- Public Version
- 1
- Public Version Date
- 2026-01-12
- Public Version Status
- New
- Public Device Record Key
- a6142e35-3644-4cb8-8924-1b0d328f9bbd
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | Anesthesiology | 868.5630 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66295 | Therapeutic agent nebulizer, ambulatory | An electrically-powered, hand-held, portable device intended to be used outside of a clinical setting (e.g., home, outdoors) to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may employ various technologies (ultrasonic, vibrating mesh, or compressor jet type) and consists of a pocket-size unit containing a reservoir to be filled with medication/fluids, and a retractable mouthpiece or attached mask. This device is not a nebulizing chamber. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00198715785128 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230379 | 000 |