Identity
- Trade Name
- TriplePlay FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- Airflow Sensor, Disposable, Small FDA UDI
- Model / Reference
- 10-10000-0401 FDA UDI
- Description
- Airflow Sensor, Disposable, Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817377020032 FDA UDI
- 510(k) Number
- K990321 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Polysomnograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polysomnograph
TriplePlay by Dymedix Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Dymedix Diagnostics, Inc.
Sources (1)
- FDA UDI e5972aa6-4c66-4a78-925a-91e978a2800a 34 fields · synced Jun 1, 2026