FDA.reportPublic FDA data

Portex

Primary DI
15019315031823
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/503/200
Published
2018-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JAYSUPPORT, BREATHING TUBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315031827PackageGS110In Commercial Distribution
55019315031821PackageGS1200In Commercial Distribution
15019315031823PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931503182735019315031827
5501931503182155019315031821
1501931503182315019315031823

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
118380146
Device count
1
Premarket exempt
true
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
10887709206172BivonaFU26JN30NSF074N2026-10-12
10887709206189BivonaFU26JN35NSF073N2026-10-12
10887709206196BivonaFT26JN40NGF076N2026-10-12
10887709206202BivonaST26JN55NSC078N2026-10-12
10887709206219BivonaHA26JS60NSB077N2026-10-12
10887709206226BivonaFT26JN60NSC079N2026-10-12
10887709206233BivonaFU26JN35NSF072N2026-10-12
10887709206240BivonaHT26JS70NSC080N2026-10-12
10887709206257BivonaFT26JN35NSE084N2026-10-12
10887709206264BivonaFT26JN55NGF081N2026-10-12
10887709206271BivonaFT26JN40NGF082N2026-10-12
10887709206288BivonaFT26JN60NGC083N2026-10-12
10887709206103BivonaFU26JN40NGE065N2026-10-09
10887709206110BivonaFT26JN50NGF066N2026-10-09
10887709206127BivonaSU26JN50NSC067N2026-10-09
10887709206134BivonaHU26JS60NSC069N2026-10-09
10887709206141BivonaHU26JS70NSC068N2026-10-09
10887709206158BivonaFU26JN45NSA070N2026-10-09
10887709206165BivonaFT26JN35NSE071N2026-10-09
10887709206011BivonaXU26JS35NGF064N2026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055146040232CLEARlineWILAmed GmbHJAY2026-08-03
04055146040843CLEARlineWILAmed GmbHJAY2026-08-03
04260217220141Oval Nooks-3G-1160-FS-O3Amtrion GmbHJAY2026-06-10
04260217222312Quick Lock-3G-912-M8-S2Amtrion GmbHJAY2026-06-10
15019517382518ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-06-01
15019517382488ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382495ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382501ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
04260217220318Circuit Support Arm ECOAmtrion GmbHJAY2026-03-30
04260217220479Vario Lock, Circuit Support Arm, 3 Joints, Bennet FootAmtrion GmbHJAY2026-03-30
10889483228579Capette™SUNMED, LLCJAY2025-12-31
20889483228576Capette™SUNMED, LLCJAY2025-12-31
10889483225462Septal-H™SUNMED, LLCJAY2025-12-16
20889483225469Septal-H™SUNMED, LLCJAY2025-12-16
10889483225431Septal-H™SUNMED, LLCJAY2025-12-15
10889483225448Septal-H™SUNMED, LLCJAY2025-12-15
10889483225455Septal-H™SUNMED, LLCJAY2025-12-15
10889483226506AirLife™SUNMED, LLCJAY2025-12-15
10889483226513AirLife™SUNMED, LLCJAY2025-12-15
10889483228586Capette™SUNMED, LLCJAY2025-12-15
10889483228593Capette™SUNMED, LLCJAY2025-12-15
10889483228609Strapette™SUNMED, LLCJAY2025-12-15
10889483228616Strapette™SUNMED, LLCJAY2025-12-15
10889483228623Capette™SUNMED, LLCJAY2025-12-15
10889483228630Capette™SUNMED, LLCJAY2025-12-15
10889483228647Capette™SUNMED, LLCJAY2025-12-15
10889483228654Strapette™SUNMED, LLCJAY2025-12-15
10889483228661Strapette™SUNMED, LLCJAY2025-12-15
10889483228692SavEar™ SUNMED, LLCJAY2025-12-15
10889483230244AirLife™SUNMED, LLCJAY2025-12-15