Identity
- Trade Name
- PeriFlux 6000 FDA UDI
- Generic Name
- Laser Doppler blood flowmeter FDA UDI
- Device Name
- PeriFlux 6000 FDA UDI
- Model / Reference
- PF 6000 FDA UDI
- Description
- PeriFlux 6000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07332834000066 FDA UDI
- 510(k) Number
- K152930 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
- 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Laser Doppler blood flowmeterTranscutaneous blood gas monitoring system
PeriFlux 6000 by Perimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Transcutaneous blood gas monitoring system.
- Attachment clips (40x) — Radiometer Medical ApS · Class II
- PSG Cable J — Sentec, Inc. · Class II
- Calibration Gas — Radiometer Basel AG · Class II
- PSG Cable K — Sentec, Inc. · Class II
- Sentec Digital Monitor — Sentec, Inc. · Class II
- PSG Cable N — Sentec, Inc. · Class II
- PSG Cable F — Sentec, Inc. · Class II
- TCM4 combi module, TCpO2/O2 combi module — Radiometer Medical ApS · Class II
Cleared under the same submission
K152930 also covers:
- PF 6001 Main Unit — Perimed, Inc.
- PF 6010 LDPM/Temp Unit — Perimed, Inc.
- PF 6040 tcpO2/pCO2 Unit — Perimed, Inc.
- PF 6050 Pressure Unit — Perimed, Inc.
- PF 6051 Pressure Accessory Kit — Perimed, Inc.
- PF 6051-M Pressure Accessory Kit Metal Bayonet — Perimed, Inc.
- PF 6052 Segmental Pressure 3 Cuff Method Kit — Perimed, Inc.
- PF 6053 Segmental Pressure 4 Cuff Method Kit — Perimed, Inc.
- PF 6054 Finger Pressure Kit — Perimed, Inc.
- PF 6055 SPP Kit — Perimed, Inc.
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
- Perimed, Inc.
Sources (1)
- FDA UDI dcaf89b6-fbf7-41a7-807e-d5f58dc72b8c 35 fields · synced May 30, 2026