FDA.reportPublic FDA data

Resp-O2 Intubating Stylette, 12 Fr

Primary DI
00840117313422
Brand
Resp-O2 Intubating Stylette, 12 Fr
Company
Dynarex Corporation
Model
36267
Published
2022-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSRStylet, Tracheal Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117313439PackageGS110In Commercial Distribution
00840117313422PrimaryGS10
00810180840002Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117313439008401173134398401173134390840117313439
00840117313422008401173134228401173134220840117313422
00810180840002008101808400028101808400020810180840002

GMDN Terms#

Term, Definition table
TermDefinition
Artificial airway stylet, single-useA long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
20
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
true
Sterilization required before use
false

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Primary DIBrandModelCatalogPublished
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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
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrou67162026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67172026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
00840117346147Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Toggle Valve, 4.55 L36390-TBULK2026-09-28
00840117346154Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Toggle Valve36391-TBULK2026-09-28
00840117346239Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Post Valve36391-PBULK2026-09-28
00840117320987Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister324092026-09-25
00840117352735dmecare Solutions Folding Beside Commode103702021-04-22
00840117352742dmecare Solutions Elongated Folding Bedside Commode103712021-04-22
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01

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