FDA.reportPublic FDA data

Ventlab

Primary DI
20889483102807
Brand
Ventlab
Company
VENTLAB, LLC
Model
VP702
Device description
19mm PEEP Valve w/ Adapter
Published
2016-09-26
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
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483102807PackageGS120In Commercial Distribution
10889483102800PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948310280720889483102807
1088948310280010889483102800

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, single-useA non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter19Millimeter
Outer Diameter30Millimeter

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
44710810117464N/AGALEMED CORPORATIONBYE2026-03-05
00856825003159N/AGALEMED CORPORATIONBYE2026-03-04
00856825003166N/AGALEMED CORPORATIONBYE2026-03-04
00856825003197N/AGALEMED CORPORATIONBYE2026-03-04
00856825003203N/AGALEMED CORPORATIONBYE2026-03-04
00850071887297Emergent RespiratoryMDL Solutions IncorporatedBYE2026-02-11
07045432116083The BAG PEEP Valve 2-10 cmH2OLaerdal Medical ASBYE2026-01-14
07045432116090The BAG PEEP Valve 5-20 cmH2OLaerdal Medical ASBYE2026-01-14
10889483228708WaterPAP™SUNMED, LLCBYE2025-12-15
10889483228715WaterPAP™SUNMED, LLCBYE2025-12-15
10889483270554AirLife™SUNMED, LLCBYE2025-12-15
00810094578541Curaplex®BOUND TREE MEDICAL, LLCBYE2025-08-06
00810094579234Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578558Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094579210Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094579227Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094579272Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
10841470100145O2-MAXPULMODYNE INCBYE2025-04-12
10841470111486Go-PAPPULMODYNE INCBYE2025-04-12
10841470111493Go-PAPPULMODYNE INCBYE2025-04-12
10841470111509Go-PAPPULMODYNE INCBYE2025-04-12
10841470111516Go-PAPPULMODYNE INCBYE2025-04-12
10841470111592Go-PAPPULMODYNE INCBYE2025-04-12
10841470111608Go-PAPPULMODYNE INCBYE2025-04-12
10841470111790Go-PAPPULMODYNE INCBYE2025-04-12
00850071887013Emergent RespiratoryMDL Solutions IncorporatedBYE2025-04-05
00850071887136Emergent RespiratoryMDL Solutions IncorporatedBYE2025-04-05
00850071887174Emergent RespiratoryMDL Solutions IncorporatedBYE2025-04-05
46923980114340N/AGaleMed Xiamen Co., Ltd.BYE2024-09-11
B00500251DMRI0AincAANESTHESIA ASSOCIATES, INC.BYE2024-06-18