Identity
- Trade Name
- NxGen Peak Flow Meter FDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 165253 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013746407 FDA UDI
- 510(k) Number
- K200832 FDA UDI
- FDA Product Code
- BZH FDA UDI
- GMDN Term
- Expiratory peak flow meter, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 300 Gram FDA UDI
Category: Expiratory peak flow meter, digital
NxGen Peak Flow Meter by Safey Medical Devices Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Expiratory peak flow meter, digital.
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Spirolab — MIR - Medical International Research S.p.A. · Class IIa
- Spirolab Plus — MIR - Medical International Research S.p.A. · Class IIa
- Spirosound — Medset Medizintechnik GmbH · Class IIa
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Model 4000 — Vitalograph Ireland, Ltd. · Class II
- Spirolab Plus ESI — MIR - Medical International Research S.p.A. · Class IIa
Cleared under the same submission
K200832 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Safey Medical Devices Private Limited
Sources (1)
- FDA UDI 99be5486-3a37-4db1-9fb2-7d043d3f10ae 37 fields · synced May 30, 2026