PROBE 403 Stainless Steel Probe

GUDID 07332834000523

PROBE 403 Stainless Steel Probe

Perimed AB

Laser Doppler blood flowmeter
Primary Device ID07332834000523
NIH Device Record Keyb4ed2193-461f-4286-9e5b-5efbcd98be8d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROBE 403 Stainless Steel Probe
Version Model NumberPROBE 403
Company DUNS354765570
Company NamePerimed AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107332834000523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPWFlowmeter, Blood, Cardiovascular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-11
Device Publish Date2018-12-11

Devices Manufactured by Perimed AB

07332834000790 - PF 6840-1 TC Remote Panel 1 Channel2023-02-09 PF 6840-1 TC Remote Panel 1 Channel
07332834000806 - PF 6840-2 TC Remote Panel 2 Channels2023-02-09 PF 6840-2 TC Remote Panel 2 Channels
07332834000820 - PF 6840-4 TC Remote Panel 4 Channels2023-02-09 PF 6840-4 TC Remote Panel 4 Channels
07332834000066 - PeriFlux 60002021-10-28 PeriFlux 6000
07332834000608 - PH 07-5 Small Tape-Fixated Probe Holder2021-06-02 PH 07-5 Small Tape-Fixated Probe Holder (5 pcs)
07332834000387 - MT B500-0L120 Straight Microtip2020-04-23 MT B500-0L120 Straight Microtip
07332834000394 - MT B500-0L240 Straight Microtip2020-04-23 MT B500-0L240 Straight Microtip
07332834000288 - TC 550 Fixation Ring for tcpO2/CO2 (50 pcs) and TC 560 Contact Liquid2019-12-13 Convenience kit including: TC 550 Fixation Ring for tcpO2/CO2 (50 pcs) TC 560 Contact Liquid (20 ml)

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