FDA.report

HUDSON RCI

Primary DI
34026704612933
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN048719
Catalog number
V5-15100
Device description
Sterile SOFT-TIP® Intubating Stylet, Adult
Published
2018-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BSRSTYLET, TRACHEAL TUBE

Product Code Classifications

CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
24026704612936PackageGS120In Commercial Distribution
34026704612933PackageGS14In Commercial Distribution
14026704612939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2402670461293624026704612936
3402670461293334026704612933
1402670461293914026704612939

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 It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed.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
Ethylene Oxide

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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