FDA.reportPublic FDA data

McGRATH MAC

Primary DI
25060272980027
Brand
McGRATH MAC
Company
AIRCRAFT MEDICAL LTD.
Model
300-000-000
Device description
Video Laryngoscope
Published
2021-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
25060272980027PackageGS125In Commercial Distribution
15060272980020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2506027298002725060272980027
1506027298002015060272980020

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity50 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

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
false
Serial number
true
Manufacturing date on label
true
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
30884521824380McGRATH MAC350-084-0002022-02-05
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

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