FDA.report

28% OXYGEN VENTURI VALVE

Primary DI
05030267000050
Brand
28% OXYGEN VENTURI VALVE
Company
INTERSURGICAL INCORPORATED
Model
0028000
Device description
28% OXYGEN VENTURI VALVE
Published
2021-10-11
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
BYFMask, Oxygen, Low Concentration, Venturi

Product Code Classifications

CodeDeviceSpecialtyClass
BYFMask, Oxygen, Low Concentration, VenturiAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05030267000043PackageGS150In Commercial Distribution
05030267000050PackageGS1200In Commercial Distribution
05030267049196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267000043050302670000435030267000043
05030267000050050302670000505030267000050
05030267049196050302670491965030267049196

GMDN Terms

TermDefinition
Venturi oxygen face maskA flexible, form-shaped device designed to be placed over the nose and mouth to deliver a near-precise mixture of air and oxygen (O2) to a patient's airway without the use of a gas mixer. The device typically includes a variety of exchangeable inserts (the venturi) that allow air entrainment in controlled amounts to provide the desired O2 concentration. It is connected to an O2 source with tubing and includes headstraps for stabilization. Adaptors are typically included for connection to a humidification source. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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

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05030267124084ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M122000051948502025-09-25
05030267124091ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M122100051948502025-09-25
05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F122200051948502025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F122300051948502025-09-25
05030267124121ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F122400051948502025-09-25
05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
05030267124138ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22122600051948502025-09-25
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT730000151948502025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULT730100151948502025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT730200151948502025-09-23
0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 519185051918502025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M519485051948502025-04-16
05030267001804TRACHEOSTOMY MASK, PAEDIATRIC120600012060002025-04-15
05030267098088PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M 116000011600002025-04-15
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE518301051830102025-04-15
00816472022552Nose Clip with Padding143560002025-04-14
0503026716154622mm Compact breathing system21580192025-04-14
0503026716175122mm Compact breathing system21580122025-04-14
05030267166367I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG890300089030002025-04-14
05030267166466I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG.890400089040002025-04-14

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