FDA.reportPublic FDA data

Ventlab

Primary DI
10889483070369
Brand
Ventlab
Company
VENTLAB, LLC
Model
2101F
Catalog number
2101F
Device description
ADULT HIGH CONCENTRATION PARTIAL NON-REBREATHER W/FITS-ALL
Published
2023-03-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYGMASK, OXYGEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889483070369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948307036910889483070369

GMDN Terms#

Term, Definition table
TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7Feet

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
038305402
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483227046VentlabR500P21R500P212023-07-18
10889483227022VentlabR500P30R500P302023-07-17
10889483228364VentlabR500P31R500P312023-07-17
10889483228371VentlabR500P32R500P322023-07-17
10889483100745VentlabHS4251-D22016-12-22
10889483096925VentlabVR2700-20VR2700-202023-06-02
10889483098585VentlabVR2400-40VR2400-402023-06-02
10889483099094VentlabVR4700-20VR4700-202023-06-02
10889483104132VentlabVR2400-100VR2400-1002023-06-02
10889483107287VentlabVR1100-40VR1100-402023-06-02
10889483111529VentlabVR5700-20VR5700-202023-06-02
10889483112175VentlabVR2100-40VR2100-402023-06-02
10889483112298VentlabVR3700-20VR3700-202023-06-02
10889483160831VentlabVR1900-20VR1900-202023-06-02
10889483160855VentlabVR2900-20VR2900-202023-06-02
10889483160879VentlabVR3900-20VR3900-202023-06-02
10889483160930VentlabVR5900-20VR5900-202023-06-02
10889483164273VentlabVR4500-20VR4500-202023-06-02
10889483164297VentlabVR5500-20VR5500-202023-06-02
10889483164334VentlabVR7500-20VR7500-202023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
09420012427632Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
09420012428585Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBYG2026-03-18
10885632467400HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467417HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10885632467462HalyardOWENS & MINOR DISTRIBUTION, INC.BYG2026-01-29
10889483221662Performance Home MedicalSUNMED, LLCBYG2025-12-31
10889483227268BiFLo™SUNMED, LLCBYG2025-12-30
10889483227275BiFLo™SUNMED, LLCBYG2025-12-30
10889483223970AirLife™SUNMED, LLCBYG2025-12-19
10889483224151AirLife™SUNMED, LLCBYG2025-12-19
10889483224298DeVilbissSUNMED, LLCBYG2025-12-19
10889483224687AirLife™SUNMED, LLCBYG2025-12-19
10889483224168AirLife™SUNMED, LLCBYG2025-12-18
10197344011117HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011742HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011759HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011773HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344042203HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-27
10197344011582HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011599HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011605HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344011612HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-14
10197344009626HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
10197344010646HUDSON RCIMEDLINE INDUSTRIES, INC.BYG2025-11-06
08697645018112ENDURE INDUSTRIESENDURE INDUSTRIESBYG2025-10-16
14026704648150HUDSON RCITELEFLEX INCORPORATEDBYG2025-07-03
14026704648235HUDSON RCITELEFLEX INCORPORATEDBYG2025-07-03