FDA.reportPublic FDA data

McGRATH MAC

Primary DI
30884521824380
Brand
McGRATH MAC
Company
AIRCRAFT MEDICAL LTD.
Model
350-084-000
Device description
Disposable Laryngoscope Blade 2
Published
2022-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCWLARYNGOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521824383PackageGS110In Commercial Distribution
30884521824380PackageGS130In Commercial Distribution
10884521824386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452182438320884521824383
3088452182438030884521824380
1088452182438610884521824386

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, single-useThe segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity 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 is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure0.62 KiloPascal1.06 KiloPascal
Handling Environment Atmospheric Pressure62 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature14 Degrees Fahrenheit158 Degrees Fahrenheit
Storage Environment Atmospheric Pressure0.62 KiloPascal1.06 KiloPascal
Storage Environment Atmospheric Pressure62 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
222254083
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884521824345McGRATH MAC350-072-0002023-06-19
30884521824311McGRATH MAC350-005-0002022-09-25
00884521214630McGrath MAC Blade Size X3X3-003-0002022-06-13
30884521816347McGRATH MAC350-072-0002022-06-13
20884521824369McGRATH MAC350-086-0002022-02-05
30884521824397McGRATH MAC350-082-0002022-02-06
20884521824376McGRATH MAC350-088-0002022-01-27
25060272980324McGRATH MAC350-013-0002022-01-17
30884521824328McGRATH MAC350-013-0002021-10-30
30884521816316McGRATH MAC350-005-0002021-10-21
20884521816333McGRATH MAC350-017-0002021-10-18
20884521824154McGRATH340-000-0002021-10-07
25060272980065McGRATH340-000-0002021-10-07
25060272980126McGRATH340-200-0002021-10-07
20884521823393McGRATH MAC301-000-0002021-09-30
20884521824352McGRATHX3-003-0002021-09-01
30884521816323McGRATH MAC350-013-0002021-08-30
20884521824338McGRATH MAC350-017-0002021-08-26
25060272980317McGRATH MAC350-005-0002021-08-02
25060272980027McGRATH MAC300-000-0002021-07-05

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