FDA.report

MedSource Airways Devices

Primary DI
00816703026410
Brand
MedSource Airways Devices
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-238211
Catalog number
Not Applicable
Device description
Berman Airway, Size:6 Lrg Adult
Published
2021-05-17
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

Related Records

Product Codes

CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications

CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816703026410PackageGS150In Commercial Distribution
00816703026403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816703026410008167030264108167030264100816703026410
00816703026403008167030264038167030264030816703026403

GMDN Terms

TermDefinition
Oropharyngeal airway, single-useA curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. 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
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

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00816703025475MedSource Emesis BagMS-17360-RCSNot Applicable2021-05-10
00816703026526MedSource Airway DevicesMS-23908-RCSNot Applicable2021-05-18
00816703027172MedSource Traction SplintMS-TLS-3-RCSNot Applicable2021-08-16
00816703020838MedSource PRN, Male Luer PrositeMS-830112016-06-30
00816703021118MedSource NP Needle Free ConnectorMS-899792016-06-30
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

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