FDA.reportPublic FDA data

Resp-O2 Endotracheal Tube With Stylette, Uncuffed, 4.5 mm

Primary DI
00840117317437
Brand
Resp-O2 Endotracheal Tube With Stylette, Uncuffed, 4.5 mm
Company
Dynarex Corporation
Model
36232
Published
2022-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042683000WELL LEAD ENDOTRACHEAL TUBEWell Lead Medical Instruments2005-02-18BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117312869PackageGS110In Commercial Distribution
00840117312876PackageGS110In Commercial Distribution
00840117317437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117312869008401173128698401173128690840117312869
00840117312876008401173128768401173128760840117312876
00840117317437008401173174378401173174370840117317437

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
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
00840117311534Resp-O2 Oxygen Supply Tubing332002021-04-22
00840117311558Resp-O2 Oxygen Supply Tubing332012021-04-22
00840117311572Resp-O2 Oxygen Supply Tubing332022021-04-22
00840117311596Resp-O2 Oxygen Supply Tubing332032021-04-22
00840117311619Resp-O2 Oxygen Supply Tubing332042021-04-22
00840117311633Resp-O2 Oxygen Supply Tubing332052021-04-22
00840117311657Resp-O2 Oxygen Supply Tubing332062021-04-22
00840117311671Resp-O2 Oxygen Supply Tubing332072021-04-22
00840117311695Resp-O2 Oxygen Supply Tubing332082021-04-22
00840117318625Resp-O2 Oxygen Tubing Inline Water Traps333022021-04-22
00840117318632Resp-O2 Oxygen Tubing 22mm I.D. x 5-7 mm Tapered Nipple Adaptors333032021-04-22
00840117318649Resp-O2 Oxygen Tubing 5-7 mm End Adaptors333042021-04-22
00840117318663Resp-O2 Oxygen Tubing Y Adaptors333062021-04-22
00840117318670Resp-O2 Oxygen Tubing Nut Nipple Adaptors333072021-04-22
00840117318687Resp-O2 Oxygen Tubing Nut Nipple Swivel Adaptors333082021-04-22
00840117318694Resp-O2 Portable Oxygen Liter Meters333092021-04-22
00840117342361Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) O2 and CO2 Tubing331982025-06-09
00840117342408Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) O2 and CO233199-F2025-06-09
00840117324008Resp-O2 Compressor, 50 PSI339522022-07-11
00840117310254Resp-O2 Oxygen Concentrator, 5L339502022-05-10

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Primary DI, Brand, Company table
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