FDA UDI
In Commercial Distribution
🇺🇸 United States
NxGen Peak Flow Meter
DI: 00860013746407
·
Model: 165253
·
SAFEY MEDICAL DEVICES PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NxGen Peak Flow Meter
- Primary DI
- 00860013746407
- Version / Model
- 165253
- Company Name
- SAFEY MEDICAL DEVICES PRIVATE LIMITED
- Labeler DUNS
- 878291677
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-27
- Public Version
- 2
- Public Version Date
- 2025-03-31
- Public Version Status
- Update
- Public Device Record Key
- 99be5486-3a37-4db1-9fb2-7d043d3f10ae
Device Description
NxGen Peak Flow Meter is intended to measure Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV1) in home healthcare environment. The device is designed for children greater than five years of age, adolescent and adult subjects.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | Anesthesiology | 868.1860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46906 | Expiratory peak flow meter, digital | A battery-powered, hand-held, electronic instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouthpiece for patient exhalation and a digital display [e.g., liquid-crystal display (LCD)]; it may include a port for communicating with a computer/tablet. The device is typically intended to monitor the respiratory status of a patient affected by chronic respiratory disorders (e.g., asthma, emphysema) in a clinical setting or the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860013746407 | GS1 |
Customer Contacts
- Phone
- +14793417542
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200832 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 300 | Gram |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 70 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 75 – 100 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity