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
10190752190535LTV10611106112025-08-26
10190752191518bellavista301.115.010301.115.0102025-07-28
10190752188860bellavista301.115.000301.115.0002025-07-25
10190752191525bellavista301.115.020301.115.0202025-07-25
10190752130364LTV2 Ventilator30509-00130509-0012025-07-16
201907522010613100A HFOV7671637671632025-07-16
10190752185197LTV228774-00128774-0012025-07-16
10190752188754LTV2 Ventilator24425-00124425-0012025-07-16
10190752188761LTV2 Ventilator24426-00124426-0012025-07-16
10190752188808LTV2 Ventilator30512-00130512-0012025-07-16
10190752190368LTV2 Ventilator29242-00129242-0012025-07-16
10190752187818iFlow301.328.020301.328.0202024-11-05
50190752187823iFlow301.328.020301.328.0202024-11-05
50190752200805LTV29660-00129660-0012024-11-05
50190752200829LTV29701-00129701-0012024-11-05
101907522010193100 HFOV11438-PMN11438-PMN2024-11-05
10190752201118LTV10696106962024-11-05
50190752201536LTV11872x1011872x102024-11-05
50190752200751LTV29659-00129659-0012024-08-13
10190752201446LTV15091-10215091-1022024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800157Adler Instrument CompanyAdler, Inc.JOL2026-05-26
40080196035435MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
40080196995555MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
00192896122802Frazier Suction TubeSONTEC INSTRUMENTS, INC.JOL2026-03-10
00810130207336MSIModern Surgical Instruments LLCJOL2026-01-23
16931918174334AllesetGRI Medical & Electronic Technology Co., Ltd.JOL2026-01-21
50192253039670CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
00840343727178GEN2SURGIX MEDICAL LLCJOL2025-12-11
16974500613491Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
16974500613507Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
57613327680725Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
30889483563414BALLARD™SUNMED, LLCJOL2025-12-01
30889483564978BALLARD™SUNMED, LLCJOL2025-12-01
30889483565562BALLARD™SUNMED, LLCJOL2025-12-01
00840314238511gSourceGSOURCE LLCJOL2025-11-24
00840314238528gSourceGSOURCE LLCJOL2025-11-24
00840314238535gSourceGSOURCE LLCJOL2025-11-24
00840314238542gSourceGSOURCE LLCJOL2025-11-24
00840314238559gSourceGSOURCE LLCJOL2025-11-24
00840314238566gSourceGSOURCE LLCJOL2025-11-24
00840314238573gSourceGSOURCE LLCJOL2025-11-24
00840314238580gSourceGSOURCE LLCJOL2025-11-24
00840314238597gSourceGSOURCE LLCJOL2025-11-24
00840314238603gSourceGSOURCE LLCJOL2025-11-24
00840314238610gSourceGSOURCE LLCJOL2025-11-24
00840314238627gSourceGSOURCE LLCJOL2025-11-24
00840314238634gSourceGSOURCE LLCJOL2025-11-24
00840314238641gSourceGSOURCE LLCJOL2025-11-24
00840314238658gSourceGSOURCE LLCJOL2025-11-24
00840314238665gSourceGSOURCE LLCJOL2025-11-24