FDA.report

HUDSON RCI

Primary DI
34026704630104
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049310
Catalog number
1066
Device description
Endotracheal Tube Holder Cushion
Published
2018-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CBHDEVICE, FIXATION, TRACHEAL TUBE

Product Code Classifications

CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704630104PackageGS150In Commercial Distribution
04026704580088PreviousGS10
14026704630100PrimaryGS10
44026704630101Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670463010434026704630104
04026704580088040267045800884026704580088
1402670463010014026704630100
4402670463010144026704630101

GMDN Terms

TermDefinition
Endotracheal tube holderA device designed to hold and stabilize an endotracheal (ET) tube when it has been intubated into a patient; it may also include a teeth protector to prevent damage to the teeth or tube during intubation. It typically consists of straps, pinch rings, cloth ties, or Velcro bands and provides the advantage of easy readjustment of the tube without retaping or the use of safety pins. This is a single-use device.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

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

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