FDA.reportPublic FDA data

ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG

Primary DI
07898671250496
Brand
ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG
Company
MAGNAMED TECNOLOGIA MEDICA SA
Model
1709953
Catalog number
1709953
Device description
KIT WITH UNIVERSAL FLOW SENSOR, FLOW SENSOR LINE, EXHALATION VALVE, AND DIAPHRAGM FOR USE WITH OXYMAG, SINGLE-USE
Published
2025-05-29
Public version status
New
Distribution status
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
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898671250496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898671250496078986712504967898671250496

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-flow sensor, single-useA sterile device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 (954) 658-2689contact@magnamedusa.com

Regulatory Flags#

DUNS number
944224603
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898671250168KIT DISPOSABLE RESPIRATORY CIRCUIT170781617078162025-04-24
07898671250175OXYMAG160688016068802023-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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20197344010070HUDSON RCIMEDLINE INDUSTRIES, INC.BYX2026-01-12
10889483234402curaplex®SUNMED, LLCBYX2025-12-31
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10889483603352Vital Signs™AirLife Finland OyBYX2025-04-22