FDA.reportPublic FDA data

BOMImed Saver

Primary DI
20629160000039
Brand
BOMImed Saver
Company
BOMImed Inc
Model
MAC 2
Catalog number
OL-3312
Device description
BOMImed Disposable Saver Laryngoscope Blade
Published
2021-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
20629160000039PackageGS120In Commercial Distribution
10629160000032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2062916000003920629160000039
1062916000003210629160000032

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
204-633-2664regulatory@bomimed.com

Regulatory Flags#

DUNS number
248200149
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
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
10629160000049BOMImed SaverMAC 3OL-33132025-08-08
20629160000046BOMImed SaverMAC 3OL-33132025-08-08
10629160000346FEATHER-FLEX2LOL-649502-00/NSP02042025-07-14
20629160000350FEATHER-FLEX2LOL-649502-00/NSP02042025-07-14
10629160000339FEATHER-FLEX3LOL-649503-00/NSP02032024-03-01
20629160000305FEATHER-FLEX3LOL-649503-00/NSP02032024-03-01
10629160012608AQUESURE FILTER HUMIDIFIEROL-040419-U00OL-040419-U002016-09-26
10629160000018INTROES POCKET BOUGIEOL-E12102OL-E121022021-08-06
10629160000032BOMImed Saver MAC 2OL-33122021-08-06
10629160000056BOMImed Saver MAC 4OL-33142021-08-06
20629160000015INTROES POCKET BOUGIEOL-E12102OL-E121022021-08-06
20629160000053BOMImed Saver MAC 4OL-33142021-08-06
20629160012605AQUESURE FILTER HUMIDIFIEROL-040419-U00OL-040419-U002016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521859999McGRATH MAC+Covidien LPCCW2026-07-03
04053755200122visionPRO Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-24
04053755213092MEDUVISION Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213108MEDUVISION Mac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213115MEDUVISION Mac 2 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213122MEDUVISION Mac 4 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
00842209139149NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139156NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139163NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139170NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139187NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139194NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139200NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00810055257607Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257614Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257621Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257638Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257645Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257652Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257669Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257676Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257683Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257690Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257706Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257713Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257720Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257737Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251346Surgical DesignSurgical Design, Inc.CCW2026-06-09