FDA.reportPublic FDA data

Portex

Primary DI
15019315020148
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/112/030
Published
2020-06-05
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
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790312000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790312000ENDOTRACHEAL TUBE W/HOLDER & CONNECTORRespiratory Support Products, Inc.1979-02-21BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315020142PackageGS110In Commercial Distribution
15019315020148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931502014235019315020142
1501931502014815019315020148

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709208497BivonaFT26KN35NGE032N2026-11-05
10887709208503BivonaFT26KN35NSF033N2026-11-05
10887709208510BivonaST26KN80NSB035N2026-11-05
10887709208527BivonaFT26KN40NGF031N2026-11-05
10887709208572BivonaFT26KN50NGF039N2026-11-05
10887709208589BivonaST26KN80NSC040N2026-11-05
10887709208596BivonaXT26HS70NSC038N2026-11-05
10887709208602BivonaFT26KN55NGC034N2026-11-05
10887709208206BivonaHU26JS55NSB221N2026-11-04
10887709208213BivonaFT26JN40NSF243N2026-11-04
10887709208282BivonaFU26KN30NGA012N2026-11-03
10887709208299BivonaFT26KN50NGF011N2026-11-03
10887709208305BivonaFT26KN50NSC004N2026-11-03
10887709208312BivonaFT26KN40NSF007N2026-11-03
10887709208329BivonaFT26KN40NGE003S2026-11-03
10887709208336BivonaFT26KN30NGE013N2026-11-03
10887709208343BivonaXT26JS50NGC230N2026-11-03
10887709208350BivonaFU26KN35NSF018N2026-11-03
10887709208367BivonaFU26KN30NSF019N2026-11-03
10887709208374BivonaFT26KN45NGF017N2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521853812ShileyCovidien LPBTR2026-10-25
10884521853829ShileyCovidien LPBTR2026-10-25
10884521853836ShileyCovidien LPBTR2026-10-25
10884521853843ShileyCovidien LPBTR2026-10-25
10884521853850ShileyCovidien LPBTR2026-10-25
10884521853867ShileyCovidien LPBTR2026-10-25
10884521853874ShileyCovidien LPBTR2026-10-25
14026704934758LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934765LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934772LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934802LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704759191SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759399SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759405SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759412SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759429SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759436SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759443SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759481SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759498SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759504SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759511SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759566SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759573SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759597SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759696SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759740SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759580SHERIDANTELEFLEX INCORPORATEDBTR2026-07-29
00810003750822KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750839KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08