FDA.reportPublic FDA data

VeyO2 Mask

Primary DI
00858545007042
Brand
VeyO2 Mask
Company
DYNASTHETICS, LLC
Model
24002
Device description
Oxygen Mask
Published
2024-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBNApparatus, Gas-Scavenging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBNApparatus, Gas-ScavengingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092031000VAPOR-CLEAR, MODEL 100Axon Medical, Inc.2010-04-16CBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10858545007049PackageGS125In Commercial Distribution
00858545007042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085854500704910858545007049
00858545007042008585450070428585450070420858545007042

GMDN Terms#

Term, Definition table
TermDefinition
Halogenated vapour absorberA refillable container (e.g., a canister) placed in an anaesthesia unit/workstation breathing circuit for the removal of halogenated vapours. This device is filled with an appropriate absorbent (e.g., activated charcoal) to chemically remove the halogenated vapours. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
801-484-3820cservice@dynasthetics.com

Regulatory Flags#

DUNS number
042681859
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858545007035SmartProngs Cannula240012024-09-24
00858545007028SovantSV10002024-09-24
10858545007032SmartProngs Cannula240012024-09-24
10858545007049VeyO2 Mask240022024-09-24
00858545007004Vapor Clean100002017-09-14
00858545007011Vapor Clean100002017-09-14
80858545007000Vapor Clean100002017-09-14
80858545007017Vapor Clean100002017-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704929426RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
14026704929433RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
14026704929440RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
00816711020424NITRONOX SCAVENGERPARKER-HANNIFIN CORPORATIONCBN2025-09-24
00860013652302DemistifierPeace Medical IncCBN2025-08-12
00816711024224SCAVENGER, EAVS, MIDASPARKER-HANNIFIN CORPORATIONCBN2025-02-21
00858545007035SmartProngs CannulaDYNASTHETICS, LLCCBN2024-09-24
00858545007028SovantDYNASTHETICS, LLCCBN2024-09-24
10858545007032SmartProngs CannulaDYNASTHETICS, LLCCBN2024-09-24
10858545007049VeyO2 MaskDYNASTHETICS, LLCCBN2024-09-24
14026704916648HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
14026704916655HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
24026704916645HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
24026704916652HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
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00813830027181FRU, Axess Scavenging Control, In-LineACCUTRON, INC.CBN2023-10-02
00813830027327FRU, Axess To Accuvac AdaptorACCUTRON, INC.CBN2023-10-02
00813830027433Axess 90 Deg Outspout ConnectorACCUTRON, INC.CBN2023-10-02
00813830027518White Axess, RFS CircuitACCUTRON, INC.CBN2023-09-21
00813830027525White Axess In-Line CircuitACCUTRON, INC.CBN2023-09-21
00813830027716ClearView Capnography AdaptersACCUTRON, INC.CBN2023-09-14
14026704734198HUDSON RCITELEFLEX INCORPORATEDCBN2023-09-12
14026704734204HUDSON RCITELEFLEX INCORPORATEDCBN2023-09-12
00816711023951SCAVENGER SUB-ASSY,SEN SEDATEPARKER-HANNIFIN CORPORATIONCBN2023-05-17
00863573000408Dynamic Gas Scavenging SystemAnesthetic Gas Reclamation, LLCCBN2023-05-03
00816711020738Nitronox Scavenger PlusPARKER-HANNIFIN CORPORATIONCBN2023-03-10