Identity
- Trade Name
- 12 uPAT Probes for Watch-PAT200U FDA UDI
- Generic Name
- Cardiovascular-risk peripheral arterial tonometry system sensor FDA UDI
- Device Name
- 12 uPAT Probes FDA UDI
- Model / Reference
- 12 uPAT Probes for Watch-PAT200U FDA UDI
- Description
- 12 uPAT Probes FDA UDI
Identifiers
- Catalog Number
- AC2101200 FDA UDI
- Primary DI / UDI-DI
- 07290109222011 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Cardiovascular-risk peripheral arterial tonometry system sensor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
12 uPAT Probes for Watch-PAT200U by Itamar Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K133859 also covers:
- Central Plus Sensor for Watch-PAT200U — Itamar Medical
- Central Plus Sensor for Watch-PAT200U — Itamar Medical
- Central Plus Sensor for Watch-PAT200U — Itamar Medical
- RESBP for Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
K153070 also covers:
- Central Plus Sensor for Watch-PAT200U — Itamar Medical
- Central Plus Sensor for Watch-PAT200U — Itamar Medical
- Central Plus Sensor for Watch-PAT200U — Itamar Medical
- RESBP for Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
K161579 also covers:
- Central Plus Sensor for Watch-PAT200U — Itamar Medical
- Central Plus Sensor for Watch-PAT200U — Itamar Medical
- Central Plus Sensor for Watch-PAT200U — Itamar Medical
- RESBP for Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
- Watch-PAT200U — Itamar Medical
K180775 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
- Itamar Medical
Sources (1)
- FDA UDI 05949858-3618-47d7-8754-4fe59292c4a3 38 fields · synced May 30, 2026