Identity
- Trade Name
- Model 4000 FDA UDI
- Generic Name
- Expiratory peak flow meter, digital FDA UDI
- Device Name
- 4000 RESPIRATORY MONITOR LUNG MON. USB GERMAN WITH REPORTS FDA UDI4000 RESPIRATORY MONITOR COPD-6 BT INT FDA UDI4000 RESPIRATORY MONITOR ASMA-1 JAPAN FDA UDI4000 RESPIRATORY MONITOR COPD-6 INT. FDA UDI4000 RESPIRATORY MONITOR LUNG AGE FDA UDI
- Model / Reference
- 4000 FDA UDI
- Description
- 4000 RESPIRATORY MONITOR LUNG MON. USB GERMAN WITH REPORTS FDA UDI4000 RESPIRATORY MONITOR COPD-6 BT INT FDA UDI4000 RESPIRATORY MONITOR ASMA-1 JAPAN FDA UDI4000 RESPIRATORY MONITOR COPD-6 INT. FDA UDI4000 RESPIRATORY MONITOR LUNG AGE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099169407036 FDA UDI15099169403502 FDA UDI15099169400396 FDA UDI15099169402000 FDA UDI15099169405001 FDA UDI
- 510(k) Number
- K073155 FDA UDI
- FDA Product Code
- BZG FDA UDI
- GMDN Term
- Expiratory peak flow meter, digital 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
No
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
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Category: Expiratory peak flow meter, digital
Model 4000 by Vitalograph Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Expiratory peak flow meter, digital.
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Cleared under the same submission
K073155 also covers:
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
- Model 4000 — Vitalograph Ireland, Ltd.
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
- Vitalograph Ireland, Ltd.
Sources (5)
- FDA UDI 5aabc8e9-c5ca-4439-b971-57d8a5ba350c 35 fields · synced Jun 8, 2026
- FDA UDI 464318c7-2ca9-4a67-9496-342634d649fd 34 fields · synced May 26, 2026
- FDA UDI 69c27439-6165-4fd7-aa81-2cf72861d75b 35 fields · synced May 27, 2026
- FDA UDI 37558f69-0e15-4611-b616-a2c1c7892d24 35 fields · synced May 27, 2026
- FDA UDI a8e24bcd-d50b-4197-ab16-cfe70911467b 34 fields · synced May 27, 2026