FDA.reportPublic FDA data

AirLife™

Primary DI
50190752130409
Brand
AirLife™
Company
VYAIRE MEDICAL, INC.
Model
AL4109
Catalog number
AL4109
Device description
Sterile 0.9% Sodium Chloride for Irrigation, USP, 110 ml
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50190752130409PackageGS125In Commercial Distribution
10190752130401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019075213040950190752130409
1019075213040110190752130401

GMDN Terms#

Term, Definition table
TermDefinition
Sterile solution storage bottle, single-useAn empty glass or plastic container, typically with a relatively narrow neck, intended for the safe storage and easy handling of sterile solutions (e.g., sterile distilled water or saline) that are used during intravenous (IV) and/or irrigation procedures; however, it is neither intended to be connected to an IV administration set nor to irrigation equipment. It is produced in a variety of sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(833)327-3284customersupport@vyaire.com

Regulatory Flags#

DUNS number
080456871
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752129993LTV11581-G11581-G2021-02-22
10190752153158VELA11571115712021-03-29
10190752114814AirLife™0024320024322020-01-15
10190752114821AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) 0024330024332020-01-15
10190752114838AirLife™0024340024342020-01-15
10190752114845AirLife™0024350024352020-01-15
10190752114852AirLife™0024370024372020-01-15
10190752114869AirLife™0024380024382020-01-15
10190752114876AirLife™0024390024392020-01-15
10190752114883AirLife™0024400024402021-04-02
10190752114890AirLife™0024420024422020-01-15
10190752114906AirLife™0024430024432020-01-15
10190752114913AirLife™0024440024442020-01-15
10190752114920AirLife™0024450024452020-01-15
10190752114937AirLife™0024460024462020-01-15
10190752114944AirLife™0024500024502020-01-15
10190752114968AirLife™0024580024582020-01-15
10190752114975AirLife™0025010025012020-01-15
10190752114982AirLife™0025020025022020-01-15
10190752114999AirLife™0025300025302020-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109110Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.JOL2026-06-10
10192253038927ArgyleCardinal Health 200, LLCJOL2026-05-07
10080196994137MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-27
10080196035458MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196995561MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196035434MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
10080196995554MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
10192253039665CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
00840183530990BR Surgical, LLCBR Surgical, LLCJOL2025-09-05
10197344153671MEDLINEMEDLINE INDUSTRIES, INC.JOL2025-05-21
10192253041866ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041873ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041880ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253038941ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253038958ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253039672ArgyleCardinal Health 200, LLCJOL2024-12-04
10192253003628ArgyleCardinal Health 200, LLCJOL2024-10-09
10192253002928ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253002935ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253002942ArgyleCardinal Health 200, LLCJOL2024-09-27
10192253057294ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057300ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057317ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057324ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057348ArgyleCardinal Health 200, LLCJOL2024-08-02
10192253057355ArgyleCardinal Health 200, LLCJOL2024-08-02