FDA.report

MedSource Oxygen Apparatus

Primary DI
00816703029435
Brand
MedSource Oxygen Apparatus
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-28375
Catalog number
Not Applicable
Device description
Oxygen Therapy Apparatus
Published
2021-06-01
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
false

Related Records

Product Codes

CodeName
BYGMask, Oxygen

Product Code Classifications

CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816703029435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816703029435008167030294358167030294350816703029435

GMDN Terms

TermDefinition
Rebreathing oxygen face maskA non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen (O2) to a patient's airway. It is made of non-conductive, soft, flexible polymers available in a range of sizes, and designed to create an airtight seal against the patient's face. The device may include tubing and various valves and connectors which may allow for connection to a central vacuum system to enable scavenging of residual (waste) anaesthetic gas from a patient in recovery; other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
041674552
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
00840155421042Nasopharyngeal Airway1011-450002025-07-15
00840155401419MedSource CathetersMS-87414Not Applicable2023-01-09
00840155406179MedSource CathetersMS-87416Not Applicable2023-01-09
00840155413870MedSource CathetersMS-87420Not Applicable2023-01-09
00840155413900MedSource CathetersMS-87422Not Applicable2023-01-09
00840155413931MedSource CathetersMS-87424Not Applicable2023-01-09
00840155413962MedSource CathetersMS-874202Not Applicable2023-01-09
00840155413993MedSource Winged CathetersMS-84214WNot Applicable2023-01-30
00840155414020MedSource Winged CathetersMS-84216WNot Applicable2023-01-30
00840155414051MedSource Winged CathetersMS-84218WNot Applicable2023-01-30
00840155414082MedSource Winged CathetersMS-842202WNot Applicable2023-01-30
00840155414112MedSource Winged CathetersMS-84220WNot Applicable2023-01-30
00840155414143MedSource Winged CathetersMS-84222WNot Applicable2023-01-30
00816703023129Elite CPR Face ShieldELITE-21105Not Applicable2021-04-20
00816703023143Elite CPR Face ShieldELITE-21106Not Applicable2021-04-20
00816703023181Elite ShearsELITE-45030Not Applicable2021-04-20
00816703023204Elite StethoscopeELITE-70031Not Applicable2021-04-20
00840155411500MedSource CathetersMS-843242Not Applicable2021-09-01
00840155412538MedSource CathetersMS-86214Not Applicable2022-10-26
00840155413641Sonostik Single Port ClearSafe Comfort CatheterMS-87214Not Applicable2022-09-26

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