FDA.reportPublic FDA data

Ventlab

Primary DI
20889483086381
Brand
Ventlab
Company
VENTLAB, LLC
Model
HS34151
Device description
HYPERINFLATION SYS W/ .5 LIT & D1 MASK
Published
2016-12-20
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
NHKResuscitator,Manual,Non Self-Inflating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHKResuscitator, Manual, Non Self-InflatingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483086381PackageGS110In Commercial Distribution
10889483086384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948308638120889483086381
1088948308638410889483086384

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, manual, single-useA non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.5Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. 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
20889483229894Disposable Medical Hyperinflation SystemSUNMED, LLCNHK2025-11-10
20889483231682Disposable Medical Hyperinflation SystemSUNMED, LLCNHK2025-11-10
10641043588727Hyperinflation SystemMERCURY ENTERPRISES, INC.NHK2025-09-11
00840118606912ENDURE INDUSTRIESENDURE INDUSTRIESNHK2023-10-12
00840118611923ENDURE INDUSTRIESENDURE INDUSTRIESNHK2023-10-12
00810071633089CuraplexBOUND TREE MEDICAL, LLCNHK2023-09-30
10889483076941VentlabVENTLAB, LLCNHK2023-07-17
10889483081020VentlabVENTLAB, LLCNHK2023-07-17
10889483095188VentlabVENTLAB, LLCNHK2023-07-17
10889483157480VentlabVENTLAB, LLCNHK2023-07-17
10889483157497VentlabVENTLAB, LLCNHK2023-07-17
10889483165478VentlabVENTLAB, LLCNHK2023-03-21
10889483165485VentlabVENTLAB, LLCNHK2023-03-21
10889483165492VentlabVENTLAB, LLCNHK2023-03-21
10889483165508VentlabVENTLAB, LLCNHK2023-03-21
10889483165515VentlabVENTLAB, LLCNHK2023-03-21
10889483165522VentlabVENTLAB, LLCNHK2023-03-21
10889483165539VentlabVENTLAB, LLCNHK2023-03-21
10889483165546VentlabVENTLAB, LLCNHK2023-03-21
10889483165553VentlabVENTLAB, LLCNHK2023-03-21
10889483165560VentlabVENTLAB, LLCNHK2023-03-21
10889483165577VentlabVENTLAB, LLCNHK2023-03-21
10889483165584VentlabVENTLAB, LLCNHK2023-03-21
10889483166895VentlabVENTLAB, LLCNHK2023-03-21
10889483166901VentlabVENTLAB, LLCNHK2023-03-21
10889483167090VentlabVENTLAB, LLCNHK2023-03-21
10889483167854VentlabVENTLAB, LLCNHK2023-03-21
10889483167861VentlabVENTLAB, LLCNHK2023-03-21
10889483167878VentlabVENTLAB, LLCNHK2023-03-21
10889483168349VentlabVENTLAB, LLCNHK2023-03-21