FDA.reportPublic FDA data

SmartProngs Cannula

Primary DI
10858545007032
Brand
SmartProngs Cannula
Company
DYNASTHETICS, LLC
Model
24001
Device description
Nasal Oxygen Cannula
Published
2024-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
10858545007032PackageGS125In Commercial Distribution
00858545007035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085854500703210858545007032
00858545007035008585450070358585450070350858545007035

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
042681859
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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858545007035SmartProngs Cannula240012024-09-24
00858545007042VeyO2 Mask240022024-09-24
00858545007028SovantSV10002024-09-24
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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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
00858545007042VeyO2 MaskDYNASTHETICS, LLCCBN2024-09-24
00858545007028SovantDYNASTHETICS, 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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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