Identity
- Trade Name
- VitaloJAK FDA UDI
- Generic Name
- Cough ambulatory recording system FDA UDI
- Device Name
- Base VitaloJAK UK(1) FDA UDI
- Model / Reference
- 7100 FDA UDI
- Description
- Base VitaloJAK UK(1) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099169710020 FDA UDI
- 510(k) Number
- K110525 FDA UDI
- FDA Product Code
- DSH FDA UDI
- GMDN Term
- Cough ambulatory recording system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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 UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cough ambulatory recording system
VitaloJAK by Vitalograph Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cough ambulatory recording system.
- Strados Labs — Strados Labs · Class II
- VitaloJAK — Vitalograph Ireland, Ltd. · Class II
- VitaloJAK — Vitalograph Ireland, Ltd. · Class II
- VitaloJAK — Vitalograph Ireland, Ltd. · Class II
Cleared under the same submission
K110525 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
- Vitalograph Ireland, Ltd.
Sources (1)
- FDA UDI cf23014f-9d37-46f5-bb58-7335b6dcef85 35 fields · synced Jun 8, 2026