FDA.report

MedSource Laryngoscope Blade

Primary DI
00840155401754
Brand
MedSource Laryngoscope Blade
Company
MEDSOURCE INTERNATIONAL LLC
Model
MS-46111
Catalog number
Not Applicable
Device description
Fiber Optic Macintosh Blade, size 1
Published
2021-07-09
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
CCWLaryngoscope, Rigid

Product Code Classifications

CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840155401754PackageGS1100In Commercial Distribution
00840155401747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840155401754008401554017548401554017540840155401754
00840155401747008401554017478401554017470840155401747

GMDN Terms

TermDefinition
Rigid intubation laryngoscope, reusableA hand-held device intended to be used by anaesthesia/emergency service personnel to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It has a handle containing batteries to power its light (a small built-in light bulb or fibreoptic light) for airway illumination, and a curved or straight blade of various designs and lengths that can be hinged/interchanged or integral. Some types can be magnetic resonance imaging (MRI) compatible. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Sterilization required before use
true

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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