Identity
- Trade Name
- PF 6040 tcpO2/pCO2 Unit FDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- PF 6040 tcpO2/pCO2 Unit FDA UDI
- Model / Reference
- PF 6040 FDA UDI
- Description
- PF 6040 tcpO2/pCO2 Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07332834000127 FDA UDI
- 510(k) Number
- K152930 FDA UDI
- FDA Product Code
- DPW FDA UDI
- GMDN Term
- Transcutaneous blood gas monitoring system 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
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
Yes
FDA UDI
Category: Transcutaneous blood gas monitoring system
PF 6040 tcpO2/pCO2 Unit by Perimed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152930 also covers:
- PF 6001 Main Unit — Perimed, Inc.
- PF 6010 LDPM/Temp 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.
- PeriFlux 6000 — 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 54397897-34af-4587-8783-2b124267c1f1 35 fields · synced May 31, 2026