FDA.reportPublic FDA data

BOMImed Saver

Primary DI
10629160000056
Brand
BOMImed Saver
Company
BOMImed Inc
Model
MAC 4
Catalog number
OL-3314
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
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
20629160000053PackageGS120In Commercial Distribution
10629160000056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2062916000005320629160000053
1062916000005610629160000056

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.

Contacts#

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

Regulatory Flags#

DUNS number
248200149
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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
20629160000015INTROES POCKET BOUGIEOL-E12102OL-E121022021-08-06
20629160000039BOMImed Saver MAC 2OL-33122021-08-06
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
06971355350147BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350154BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350161BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350178BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350512BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350529BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
06971355350888BESDATAShenzhen BesdataTechnology Co., LTD.CCW2026-09-04
00190776427580MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427597MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427603MillenniumAvalign Technologies, Inc.CCW2026-08-26
00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
14026704760548PILLINGTELEFLEX INCORPORATEDCCW2026-07-31
25056094503100PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503117PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503124PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503131PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503148PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503155PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
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25056094503186PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
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25056094503254PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31
25056094503261PROACT SmoothlinePROACT MEDICAL LIMITEDCCW2026-07-31