Airsonett AIR-4 A-1100

GUDID 07350128750022

Exchangeable filter to Airsonett AIR-4

Airsonett AB

Mobile laminar airflow unit
Primary Device ID07350128750022
NIH Device Record Keydb1c7ff7-8761-4c17-8685-904a52655c28
Commercial Distribution StatusIn Commercial Distribution
Brand NameAirsonett AIR-4 A-1100
Version Model NumberA-1100
Company DUNS775813962
Company NameAirsonett 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS107350128750022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRFCleaner, Air, Medical Recirculating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-09
Device Publish Date2023-02-01

Devices Manufactured by Airsonett AB

07350128750015 - Airsonett AIR-42023-02-09 Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett an
07350128750022 - Airsonett AIR-4 A-11002023-02-09Exchangeable filter to Airsonett AIR-4
07350128750022 - Airsonett AIR-4 A-11002023-02-09 Exchangeable filter to Airsonett AIR-4

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