FDA.reportPublic FDA data

PF 6040 tcpO2/pCO2 Unit

Primary DI
07332834000127
Brand
PF 6040 tcpO2/pCO2 Unit
Company
Perimed AB
Model
PF 6040
Device description
PF 6040 tcpO2/pCO2 Unit
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DPWFlowmeter, Blood, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPWFlowmeter, Blood, CardiovascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152930000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152930000PeriFlux6000Perimed AB2016-05-05DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332834000127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332834000127073328340001277332834000127

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous blood gas monitoring systemAn assembly of mains electricity (AC-powered) devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters, typically blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), haemoglobin oxygen saturation (SpO2), and/or venous blood oxygenation through the jugular vein (SjvO2); often with pulse rate. It consists primarily of a probe for gas detection (e.g., via transcutaneous gas diffusion, or using light spectroscopy) placed on the patient’s skin, and an oximetry monitor for the measurement, analysis, and display of data; patient adhesives and connecting cables may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal110 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
354765570
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07332834000790PF 6840-1 TC Remote Panel 1 ChannelPF 6840-12023-02-01
07332834000806PF 6840-2 TC Remote Panel 2 ChannelsPF 6840-22023-02-01
07332834000820PF 6840-4 TC Remote Panel 4 ChannelsPF 6840-42023-02-01
07332834000066PeriFlux 6000PF 60002021-10-20
07332834000288TC 550 Fixation Ring for tcpO2/CO2 (50 pcs) and TC 560 Contact Liquid90-000372019-12-05
07332834000295TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength Adhesive (50 pcs) and TC 56090-000542019-12-05
07332834000103PF 6001 Main UnitPF 60012016-09-13
07332834000240TC 550 Fixation Ring for tcpO2/CO2TC 5502017-02-14
07332834000257TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength AdhesiveTC 5552017-02-14
07332834000264TC 560 Contact LiquidTC 5602016-09-13
07332834000271TC 550 TC 560 Fixation Ring and Contact Liquid for tcpO2/CO2 90-000422017-02-14
07332834000332PeriSoft for Windows Examination ManagerPSW ExM2016-09-13
07332834000349PeriSoft for Windows 2.5PSW 2.52016-09-13
07332834000400PF 5001 Main UnitPF 50012016-09-13
07332834000417PF 5002 Basic Main UnitPF 50022016-09-13
07332834001162PF 6051-M Pressure Accessory Kit Metal BayonetPF 6051-M93-003252024-12-13
07332834001117PF 6051 Pressure Accessory KitPF 605193-001862023-01-31
07332834001124PF 6052 Segmental Pressure 3 Cuff Method KitPF 605293-002262023-01-31
07332834001131PF 6053 Segmental Pressure 4 Cuff Method KitPF 605393-002302023-01-31
07332834001148PF 6054 Finger Pressure KitPF 605493-002312023-01-31

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