MicroAire®

GUDID 00847399006424

SYRINGE ADAPTER, TOOMEY TO LUER

Microaire Surgical Instruments LLC

Collection syringe adaptor, single-use

Primary Device ID	00847399006424
NIH Device Record Key	906dad5c-7555-4c51-8d87-3144f72473e9
Commercial Distribution Status	In Commercial Distribution
Brand Name	MicroAire®
Version Model Number	ASP-ADP-2
Company DUNS	103056420
Company Name	Microaire Surgical Instruments LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Operating and Storage Conditions

Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal
Handling Environment Temperature	Between -18 Degrees Celsius and 49 Degrees Celsius
Handling Environment Humidity	Between 0 Percent (%) Relative Humidity and 91 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 86 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847399006424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

BK220674

FDA Product Code

MUU	System, Suction, Lipoplasty