FDA.reportPublic FDA data

Ventlab

Primary DI
10889483077450
Brand
Ventlab
Company
VENTLAB, LLC
Model
301-062213
Device description
MDI, Spacer, Rigid, Fluted, Antistatic
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483077457PackageGS150In Commercial Distribution
10889483077450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948307745720889483077457
1088948307745010889483077450

GMDN Terms#

Term, Definition table
TermDefinition
AtomizerA non-ventilatory device that is intended to provide liquid medication in aerosolized form into the air that a patient will breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00General Warehouse. Do not get wet.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
038305402
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30889483644540AirFlowAF5142MB-PWAF5142MB-PW2025-11-25
30889483631526AirFlow™AF2102MCP-3AF2102MCP-32025-02-03
30889483631533AirFlow™AF5102MC-PAF5102MC-P2025-01-31
10889483555675VentlabAF2142MB-M5EAF2142MB-M5E2024-03-12
10889483555682VentlabAF5000MB-EAF5000MB-E2024-03-12
10889483555699VentlabAF5040MB-EAF5040MB-E2024-03-12
10889483555705VentlabAF5040MBP-EAF5040MBP-E2024-03-12
10889483555712VentlabAF5140MB-EAF5140MB-E2024-03-12
10889483555729VentlabAF5140MBP-EAF5140MBP-E2024-03-12
10889483555736VentlabAF5142MBP-EAF5142MBP-E2024-03-12
10889483555743VentlabAF2000MB-EAF2000MB-E2024-03-12
10889483555750VentlabAF2040MB-EAF2040MB-E2024-03-12
10889483555767VentlabAF2040MBP-EAF2040MBP-E2024-03-12
10889483555774VentlabAF2140MB-EAF2140MB-E2024-03-12
10889483555781VentlabAF2140MBP-EAF2140MBP-E2024-03-12
10889483555798VentlabAF2142MBP-EAF2142MBP-E2024-03-12
10889483555804VentlabAF2144MB-EAF2144MB-E2024-03-12
10889483555811VentlabAF5140MB-ZAF5140MB-Z2024-03-12
10889483555828VentlabAF5140MBP-ZAF5140MBP-Z2024-03-12
10889483555835VentlabAF5040MBP-ZAF5040MBP-Z2024-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00604351673106MC 300 Reusable NebulizerMonaghan Medical CorporationCAF2026-05-26
44710810080584N/AGALEMED CORPORATIONCAF2026-03-05
44710810082120N/AGALEMED CORPORATIONCAF2026-03-05
44710810082960N/AGALEMED CORPORATIONCAF2026-03-05
44710810084988N/AGALEMED CORPORATIONCAF2026-03-05
44710810085060N/AGALEMED CORPORATIONCAF2026-03-05
44710810085947N/AGALEMED CORPORATIONCAF2026-03-05
44710810086005N/AGALEMED CORPORATIONCAF2026-03-05
44710810088283N/AGALEMED CORPORATIONCAF2026-03-05
44710810088962N/AGALEMED CORPORATIONCAF2026-03-05
44710810089488N/AGALEMED CORPORATIONCAF2026-03-05
44710810110847N/AGALEMED CORPORATIONCAF2026-03-05
44710810112650N/AGALEMED CORPORATIONCAF2026-03-05
20889483230005VixOne™SUNMED, LLCCAF2026-02-11
00199874417059AirpulseAIRPULSE LTDCAF2026-02-03
00810178886371Vive BreatheVIVE HEALTH LLCCAF2026-02-02
00810178884049Vive BreatheVIVE HEALTH LLCCAF2026-01-30
00810178884681Vive BreatheVIVE HEALTH LLCCAF2026-01-30
00810178886814Vive BreatheVIVE HEALTH LLCCAF2026-01-30
04719873130153AdheRespHCMED INNOVATIONS CO., LTD.CAF2026-01-29
04719873130207Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
04719873130214Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
04719873130351Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
00848530107932Nebulizer and CompressorSUNSET HEALTHCARE SOLUTIONS, INC.CAF2026-01-26
04719873131228Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-22
04719873131235Pulmogine®HCMED INNOVATIONS CO., LTD.CAF2026-01-22
46923980103689N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105430N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105461N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105485N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22