Infusion Sets, Bien Air

GUDID 08056646503889

Irrigation Line KM (10/pkg)

OMNIA SRL

Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system
Primary Device ID08056646503889
NIH Device Record Keyea620a7b-53cd-4496-aa9a-c8b6eaad91bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfusion Sets, Bien Air
Version Model Number32.F0284.00
Company DUNS447696675
Company NameOMNIA SRL
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108056646503889 [Unit of Use]
GS108056646503896 [Primary]

FDA Product Code

EFSUnit, Oral Irrigation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-17
Device Publish Date2021-08-09

On-Brand Devices [Infusion Sets, Bien Air]

08056646503889Irrigation Line KM (10/pkg)
08056646503865Irrigation Line (10/pkg)
J00715016350011Irrigation Line KM (10/pkg)
J00715009840101Irrigation Line (10/pkg)

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