FDA.reportPublic FDA data

Ventlanb

Primary DI
10889483081167
Brand
Ventlanb
Company
VENTLAB, LLC
Model
AF2142MB-2
Device description
AirFlow Sm. Adult/Pediatric Resuscitator with Integrated Manometer, B/V Filter, 40cm Pop-Off, Bag Reservoir, and Size 3 & 4 Masks
Published
2016-11-16
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
BTMVentilator, Emergency, Manual (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483081164PackageGS110In Commercial Distribution
10889483081167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948308116420889483081164
1088948308116710889483081167

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Do not get wet.

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
10889483075494VentlabAF2140MB-N2016-11-16
10889483075876VentlabAF2000MB2016-11-14
10889483076019VentlabAF2100MB-32016-11-14
10889483076286VentlabAF2140MB-D42016-11-16
10889483077566VentlabAF2140MB-I2016-11-16
10889483077573Ventlab, LLCAF2140MB-PWAF2140MB-PW2023-06-26
10889483077931VentlabAF2142MB-32016-11-16
10889483078068VentlabAF2140MB2016-11-16
10889483078167VentlabAF2042MB2016-11-14
10889483078181VentlabAF2100MB-MMC2016-11-14
10889483081143VentlabAF2140MB-22016-11-16
10889483081150VentlabAF2140MB-K2016-11-16
10889483081181VentlabAF2142MC-32016-11-16
10889483085752VentlabAF2042MB-K2016-11-14
10889483085769VentlabAF2102MC-PT2016-11-14
10889483087787VentlabAF2140MB-32016-11-16
10889483088128VentlabAF2142MB-K2016-11-16
10889483089262VentlabAF2142OB2016-11-16
10889483090237VentlabAF2142MB2016-11-16
10889483090732VentlabAF2040MBP2016-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10641043561782CPR-2 BagMERCURY ENTERPRISES, INC.BTM2026-11-05
10889483653371AirlifeVENTLAB, LLCBTM2026-10-15
10889483654286AirlifeVENTLAB, LLCBTM2026-10-15
10889483654293AirlifeVENTLAB, LLCBTM2026-10-15
10889483654309AirlifeVENTLAB, LLCBTM2026-10-15
10889483654316AirlifeVENTLAB, LLCBTM2026-10-15
10889483631522AirFlow™VENTLAB, LLCBTM2025-02-03
10889483555675VentlabVENTLAB, LLCBTM2024-03-12
10889483555743VentlabVENTLAB, LLCBTM2024-03-12
10889483555750VentlabVENTLAB, LLCBTM2024-03-12
10889483555767VentlabVENTLAB, LLCBTM2024-03-12
10889483555774VentlabVENTLAB, LLCBTM2024-03-12
10889483555798VentlabVENTLAB, LLCBTM2024-03-12
10889483555804VentlabVENTLAB, LLCBTM2024-03-12
10889483555842VentlabVENTLAB, LLCBTM2024-03-12
10889483555859VentlabVENTLAB, LLCBTM2024-03-12
10889483565643AirFlowVENTLAB, LLCBTM2023-12-14
10889483111185VentlabVENTLAB, LLCBTM2023-07-12
10889483073315VentlabVENTLAB, LLCBTM2023-06-28
10889483167083VentlabVENTLAB, LLCBTM2023-06-28
10889483077573Ventlab, LLCVENTLAB, LLCBTM2023-06-26
10889483172230Ventlab, LLCVENTLAB, LLCBTM2023-06-26
00840117326002RespO2 Manual Pulmonary Resuscitator (MPR)Dynarex CorporationBTM2023-01-09
10080196659777MedlineMEDLINE INDUSTRIES, INC.BTM2022-10-28
10193489001945MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
06946430410832CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
06946430410856CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
06946430410870CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
10193489001150MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489001167MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14