Identity
- Trade Name
- PROBE 413 Integrating Probe FDA UDI
- Generic Name
- Laser Doppler blood flowmeter FDA UDI
- Device Name
- PROBE 413 Integrating Probe (including PH 13 (10 pcs)) FDA UDI
- Model / Reference
- PROBE 413 FDA UDI
- Description
- PROBE 413 Integrating Probe (including PH 13 (10 pcs)) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07332834000493 FDA UDI
- 510(k) Number
- K974285 FDA UDI
- FDA Product Code
- DPW FDA UDI
- GMDN Term
- Laser Doppler blood flowmeter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2100 FDA UDI
- Commercial Distribution
- Not 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
PROBE 413 Integrating Probe by Perimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Perimed, Inc.
Sources (1)
- FDA UDI c7334687-abfb-426d-ac5e-dba1ef54f9ac 35 fields · synced May 30, 2026