Portex

Primary DI
10351688018809
Brand
Portex
Company
ICU MEDICAL, INC.
Model
512100
Published
2015-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTOTube, tracheostomy (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903730000D.I.C. TRACHEOSTOMY TUBES & LARYNGECTOMY TUBESConcord/Portex1990-09-25BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10351688018809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1035168801880910351688018809

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, single-useA hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10887709194738BivonaFP26FN35NSA007N2026-06-02
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10887709193830BivonaZU26EN70NSC132N2026-06-01
10887709193847BivonaZU26EN75NSC131N2026-06-01
10887709194257BivonaSP26EN40NGE157S2026-06-01
10887709194264BivonaFF26EN55NSF148S2026-06-01
10887709194271BivonaSU26EN45NGG150N2026-06-01
10887709194288BivonaFU26EN35NSF173N2026-06-01

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