FDA.report

Trach Tube Holder - Adult (19" length)

Primary DI
00616784462035
Brand
Trach Tube Holder - Adult (19" length)
Company
DYNAREX CORPORATION
Model
4620
Published
2019-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CBHDevice, Fixation, Tracheal Tube

Product Code Classifications

CodeDeviceSpecialtyClass
CBHDevice, Fixation, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784462035PrimaryGS10
00616784462011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784462035006167844620356167844620350616784462035
00616784462011006167844620116167844620110616784462011

GMDN Terms

TermDefinition
Tracheostomy tube neck holder, reusableA noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
50
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
true
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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