FDA.report

Resp-O2 Intubating Stylette, 14 FR

Primary DI
00840117315228
Brand
Resp-O2 Intubating Stylette, 14 FR
Company
DYNAREX CORPORATION
Model
36268
Published
2022-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BSRStylet, Tracheal Tube

Product Code Classifications

CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840117315198PackageGS110In Commercial Distribution
00840117315235PrimaryGS10
00840117315228Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117315198008401173151988401173151980840117315198
00840117315235008401173152358401173152350840117315235
00840117315228008401173152288401173152280840117315228

GMDN Terms

TermDefinition
Artificial airway stylet, single-useA sterile, 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 It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed.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.

Sterilization Methods

Method

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
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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