FDA.reportPublic FDA data

AM MAC-1 Macintosh Blade

Primary DI
M996AMMAC10
Brand
AM MAC-1 Macintosh Blade
Company
INSTRUMENTATION INDUSTRIES, INCORPORATED
Model
AM MAC-1
Catalog number
AM MAC-1
Device description
Curved Macintosh laryngoscope blade Size 1 - 87mm
Published
2021-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
M996AMMAC10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Laryngoscope blade, reusableThe 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length87Millimeter

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Moist Heat or Steam Sterilization""]"
High-level Disinfectant;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-412-854-1133dorisw@iiimedical.com

Regulatory Flags#

DUNS number
053146767
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M996SR75C0SR 75-C Swivel Barbed Tubing AdapterSR 75-C ClearSR 75-C2026-04-01
M996KC211D0KC 211-D 60 degree Angle Wye ConnectorKC 211-DKC 211-D2019-05-11
M996KC212D0KC 212-D 90 degree Angle Wye ConnectorKC 212-DKC 212-D2019-05-11
M996KC213D0KC 213-D 60 degree Angle Wye ConnectorKC 213-DKC 213-D2019-05-11
M996KC213D6KC 213-D 60 degree Angle Wye ConnectorKC 213-DKC 213-D2019-05-11
M996NC125850NC 12585 Nose ClipNC 12585NC 125852024-07-16
M996SH74BK0SH 74-BK Barbed Tubing AdapterSH 74-BK - BlackSH 74-BK2017-03-31
M996SH74BL0SH 74-BL Barbed Tubing AdapterSH 74-BL - BlueSH 74-BK2017-03-31
M996SH74C0SH 74-C Barbed Tubing AdapterSH 74-C - ClearSH 74-C2017-03-31
M996SH74G0SH 74-G Barbed Tubing AdapterSH 74-G - GreenSH 74-G2017-03-31
M996SH74W0SH 74-W Barbed Tubing AdapterSH 74-W - WhiteSH 74-W2017-03-31
M996SH74Y0SH 74-Y Barbed Tubing AdapterSH 74-Y - YellowSH 74-Y2017-03-31
M996SH75BK0SH 75-BK Barbed Tubing AdapterSH 75-BK - BlackSH 75-BK2017-03-31
M996SH75BL0SH 75-BL Barbed Tubing AdapterSH 75-BL - BlueSH 75-BL2017-03-31
M996SH75C0SH 75-C Barbed Tubing AdapterSH 75-C - ClearSH 75-C2017-03-31
M996SH75G0SH 75-G Barbed Tubing AdapterSH 75-G - GreenSH 75-G2017-03-31
M996SH75W0SH 75-W Barbed Tubing AdapterSH 75-W - WhiteSH 75-W2017-03-31
M996SH75Y0SH 75-Y Barbed Tubing AdapterSH 75-Y - YellowSH 75-Y2017-03-31
M996BE1690BE 169 Oxygen Tank Wrench with Security CableBE 1692017-05-31
M996BE169W0BE 169-W Oxygen Tank WrenchBE 169-W2017-05-31

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04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
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