Identity
- Trade Name
- In-Check FDA UDI
- Generic Name
- Incentive spirometer FDA UDI
- Device Name
- IN-CHECK ORAL ATM FDA UDI
- Model / Reference
- 3109750ATM FDA UDI
- Description
- IN-CHECK ORAL ATM FDA UDI
Identifiers
- Catalog Number
- 3109750ATM FDA UDI
- Primary DI / UDI-DI
- 05023323001146 FDA UDI
- 510(k) Number
- K980960 FDA UDI
- FDA Product Code
- BZH FDA UDI
- GMDN Term
- Incentive spirometer 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Incentive spirometer
In-Check by Clement Clarke International Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K980960 also covers:
- In-Check — CLEMENT CLARKE INTERNATIONAL LIMITED
- In-Check — CLEMENT CLARKE INTERNATIONAL LIMITED
- In-Check — CLEMENT CLARKE INTERNATIONAL LIMITED
- In-Check — CLEMENT CLARKE INTERNATIONAL LIMITED
- In-Check — CLEMENT CLARKE INTERNATIONAL LIMITED
- In-Check — CLEMENT CLARKE INTERNATIONAL LIMITED
- In-Check — CLEMENT CLARKE INTERNATIONAL LIMITED
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
- Clement Clarke International Limited
Sources (1)
- FDA UDI 79566f39-dcb5-4798-a4ba-2ad1407a3ea9 36 fields · synced Jun 8, 2026