FDA.report

HUDSON RCI

Primary DI
24026704646993
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN914327
Catalog number
81804
Published
2018-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
24026704646993PackageGS112In Commercial Distribution
14026704646996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2402670464699324026704646993
1402670464699614026704646996

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.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and keep dry. Store in a cool and dry place, protected from light and ozone (no ultraviolet light if applicable)
Special Storage Condition, Specify00Keep away from sunlight and keep dry. Store in a cool and dry place, protected from light and ozone (no ultraviolet light if applicable)

Sterilization Methods

Method

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
true
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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30841156104058SUPERCROSS530953092026-03-23
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