FDA.reportPublic FDA data

PH 07-5 Small Tape-Fixated Probe Holder

Primary DI
17332834000605
Brand
PH 07-5 Small Tape-Fixated Probe Holder
Company
Perimed AB
Model
PH 07-5
Device description
PH 07-5 Small Tape-Fixated Probe Holder (5 pcs)
Published
2021-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K974285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974285000PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNITPerimed, Inc.1998-05-28DPW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17332834000605PrimaryGS10
07332834000608Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1733283400060517332834000605
07332834000608073328340006087332834000608

GMDN Terms#

Term, Definition table
TermDefinition
Laser Doppler blood flowmeterA mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/sensors connected to a software-controlled control/visual display unit.

Regulatory Flags#

DUNS number
354765570
Device count
5
DM exempt
true
Lot or batch
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
07332834000127PF 6040 tcpO2/pCO2 UnitPF 60402016-09-13
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

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