FDA.reportPublic FDA data

Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR

Primary DI
00840117313361
Brand
Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FR
Company
Dynarex Corporation
Model
36261
Device description
Sterile-Eo
Published
2022-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KBIBougie, Eustachian

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBIBougie, EustachianEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117313378PackageGS120In Commercial Distribution
00840117313361PrimaryGS10
00840117322981Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117313378008401173133788401173133780840117313378
00840117313361008401173133618401173133610840117313361
00840117322981008401173229818401173229810840117322981

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube introducer, single-useA device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
10
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117346307Vital Signs Stand, Compatible with item 10843108562026-06-08
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)8150BLK2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)8161BLK2026-06-08
00840117327610Titan-700 Bariatric Rollator102172023-12-28
00840117325968Platform Attachment102122023-03-24
00840117326026Dynarex Bari + Max Bariatric Platform Attachment102132023-03-24
00616784020419Vivid-Flex, Adjustable Height Rollator102042019-10-07
00616784021515Compact Steerable Knee Walker, With Basket, Steel102152019-10-08
00616784021614Steerable Knee Walker with Basket102162019-10-08
00616784020815DynaGo Duo Transport Rollator With 7.5" Casters and Plastic Footrest102082019-11-13
00840117325913Bari + Max Bariatric HD Steel Walker, Weight Capacity 700 lb.101692023-01-09
00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
00616784020013DynaGo Zoom - Aluminum Rollator with 3" Wheels102002019-10-07
00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
00616784020211Vivid-Terrain, Rollator with 7.5" Caster102022019-10-07
00616784020310Titan-500 Bariatric Rollator102032019-10-07
00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117313347Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FRDynarex CorporationKBI2022-05-17
00810180840019Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FRDynarex CorporationKBI2022-05-17
08401173133472Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FRDYNAREX CORPORATIONKBI2022-05-17
00840117322974Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FRDYNAREX CORPORATIONKBI2022-05-17