FDA.reportPublic FDA data

Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR

Primary DI
08401173133472
Brand
Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR
Company
DYNAREX CORPORATION
Model
36260
Published
2022-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00840117313354PackageGS120In Commercial Distribution
00840117313347PrimaryGS10
08401173133472Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117313354008401173133548401173133540840117313354
00840117313347008401173133478401173133470840117313347
08401173133472084011731334728401173133472

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
10
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117348707dmecare Solutions Elongated Folding Bedside Commode, With Collapsible Bucket10373C2026-10-30
00840117310346Resp-O2 Oxygen Cylinder Cart, Single366202026-10-28
00840117310353Resp-O2 Oxygen Cylinder Cart, Dual366212026-10-28
00840117310360Resp-O2 Oxygen Cylinder Holder, Wheelchair Mount366222026-10-28
00840117310278Resp-O2 Oxygen Cylinder Wrenches, Black366002026-10-26
00840117346222Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Post Valve, 4.55 L36390-PBULK2026-10-26
00840117322547Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363702026-10-23
00840117322554Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363712026-10-23
00840117322561Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363722026-10-23
00840117322578Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363732026-10-23
00840117322585Resp-O2 Oxygen Regulator CGA 540-Style, DISS Outlet, Brass-Sleeved363742026-10-23
00840117348684dmecare Solutions Folding Bedside Commode, With Collapsible Bucket10372C2026-10-23
00840117339057Durma+ Transparent Film Dressing, Frame Style, Sterile36472024-12-13
00840117339088Durma+ Transparent Film Dressing, Frame Style36482024-12-13
00616784319438Compress Bandages, Offset, Sterile31942021-06-21
00840117307360Child Face Masks2207-CHCR2021-06-21
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24512026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24522026-10-01
00616784316925Cotton Balls, Large31692026-10-01
00616784317021Cotton Balls, Medium31702026-10-01

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
00840117322974Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FRDYNAREX CORPORATIONKBI2022-05-17
00840117313361Resp-O2 Endotracheal Tube Introducer (Bougie), Adult, 15 FRDynarex CorporationKBI2022-05-16