PROBE 413 Integrating Probe

GUDID 07332834000493

PROBE 413 Integrating Probe (including PH 13 (10 pcs))

Perimed AB

Laser Doppler blood flowmeter
Primary Device ID07332834000493
NIH Device Record Keyc7334687-abfb-426d-ac5e-dba1ef54f9ac
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROBE 413 Integrating Probe
Version Model NumberPROBE 413
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332834000493 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.