Identity
- Trade Name
- NxGen Pocket Spirometer FDA UDI
- Generic Name
- Diagnostic spirometer, professional FDA UDI
- Device Name
- NxGen Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. NxGen Pocket Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Pocket Spirometer is intended to be used under Home Healthcare environment. FDA UDI
- Model / Reference
- 165221 FDA UDI
- Description
- NxGen Pocket Spirometer is a Diagnostic Spirometer which connects to a Mobile Phone to carry out tests. NxGen Pocket Spirometer is intended to be used by patients above 5 years of age to perform basic lung function tests under the instruction of a physician or practitioner licensed by law to measure the health of the lung. Pocket Spirometer is intended to be used under Home Healthcare environment. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860013746414 FDA UDI
- 510(k) Number
- K201002 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Diagnostic spirometer, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1840 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
Yes
FDA UDI
Over-the-Counter
No
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: Diagnostic spirometer, professional
NxGen Pocket Spirometer by Safey Medical Devices Private Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic spirometer, professional.
- Alpha — Vitalograph Ireland, Ltd. · Class II
- Chartis Console — Pulmonx Corporation · Class II
- Alpha — Vitalograph Ireland, Ltd. · Class II
- Pulmonx Chartis Tablet Console — Pulmonx Corporation · Class II
- Jaeger — Jaeger Medical GmbH · Class II
- Vyaire — Jaeger Medical GmbH · Class II
- SPIROVIT SP-250 — Schiller Corp. · Class II
- Alpha — Vitalograph Ireland, Ltd. · Class II
Cleared under the same submission
K201002 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Safey Medical Devices Private Limited
Sources (1)
- FDA UDI 5e028e59-5191-4653-8ca3-914c2fe4b1f9 37 fields · synced Jun 8, 2026