FDA.report

Ventlab

Primary DI
10889483166901
Brand
Ventlab
Company
VENTLAB, LLC
Model
2004HZ
Catalog number
2004HZ
Device description
1 Liter Hyperinflation System w/ manometer, size 2 mask, 40cm pop-off & 6" flex neck
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NHKResuscitator, manual, non self-inflating

Product Code Classifications

CodeDeviceSpecialtyClass
NHKResuscitator, Manual, Non Self-InflatingAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889483166901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088948316690110889483166901

GMDN Terms

TermDefinition
Airway pressure monitor, non-poweredA mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume1Liter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags

DUNS number
038305402
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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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 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
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10889483165539VentlabVENTLAB, LLCNHK2023-03-21
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