FDA.reportPublic FDA data

Oxy2Mask O2/EtCO2

Primary DI
00620974003182
Brand
Oxy2Mask O2/EtCO2
Company
Southmedic Incorporated
Model
OM-2125-MDT
Catalog number
OM-2125-MDT
Device description
Oxy2Mask O2/EtCO2 Adult Mask with Microsteam connector
Published
2023-12-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222511000Oxy2ProSouthmedic, Inc.2023-11-21CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10620974003189PrimaryGS10
00620974003182Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062097400318910620974003189
00620974003182006209740031826209740031820620974003182

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-sampling/monitoring setA collection of non-sterile devices intended to be integrated within a breathing circuit to enable interface of gases between the breathing circuit and a respiratory monitoring device for sampling the patient's expired gas for measurements of pressure, flow and/or gas analysis [e.g., end-tidal carbon dioxide (EtCO2) concentration]. It includes both a tube/mask breathing circuit connector with sampling ports (sometimes referred to as a spirometry sensor) and gas-sampling/monitoring respiratory tubing; no electronic devices are included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(705)726-9383custserv@southmedic.com

Regulatory Flags#

DUNS number
246848147
Device count
25
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10620974004483Southmedic Instrument Cleaning BrushesPK45601PK456012026-05-19
10620974004490Southmedic Instrument Cleaning BrushesPK456000PK4560002026-05-19
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10620974004568Southmedic Instrument Cleaning BrushesPK45306PK453062026-05-19
10620974003349SPSS Safety Scalpel Metal Handle73-8041-173-8041-12023-02-07
10620974001338Southmedic Instrument Cleaning BrushesPK45DS01PK45DS012026-01-07
10620974004506Southmedic Instrument Cleaning BrushesPK45DS02PK45DS022026-01-07
10620974004513Southmedic Instrument Cleaning BrushesPK45DS03PK45DS032026-01-07
10620974004520Southmedic Instrument Cleaning BrushesPK45DS04PK45DS042026-01-07
10620974004537Southmedic Instrument Cleaning BrushesPK45DS05PK45DS052026-01-07
10620974004285BetterShieldMXFS-40-FOAMMXFS-40-FOAM2025-12-19
00620974004288BetterShieldMXFS-40-FOAMMXFS-40-FOAM2025-12-19
10620974002069BetterShield™MXFS-FOAMMXFS-FOAM2020-10-02
10620974002076BetterShield™MXFS-50-FOAMMXFS-50-FOAM2020-10-02
10620974002083BetterShield™MXFS-SAMPLEMXFS-SAMPLE2020-10-02
00620974002048BetterShield™MXFS-25MXFS-252020-10-02
10620974004322Southmedic Instrument Cleaning BrushesPK45602PK456022025-08-28
10620974004339Southmedic Instrument Cleaning BrushesPK45603PK456032025-08-28
10620974004346Southmedic Instrument Cleaning BrushesPK45604PK456042025-08-28
10620974004353Southmedic Instrument Cleaning BrushesPK45605PK456052025-08-28

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