FDA.reportPublic FDA data

Portex

Primary DI
15019315058851
Brand
Portex
Company
ICU MEDICAL, INC.
Model
Z110N-12
Published
2016-10-19
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
BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL
CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSYCatheters, Suction, TracheobronchialAnesthesiology1
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315058855PackageGS120In Commercial Distribution
15019315058851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931505885535019315058855
1501931505885115019315058851

GMDN Terms#

Term, Definition table
TermDefinition
Tracheobronchial suction/insufflation catheter, single-lumenA sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a single lumen tube for alternating suction and insufflation. This is a single-use device.

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
00887709098602ICU Medical, Inc.DS19022026-05-28
10887709194431BivonaFU26EN35NGE188N2026-05-28
10887709194448BivonaFU26EN35NGE189N2026-05-28
10887709194455BivonaXT26ES70NSC190N2026-05-28
10887709194462BivonaSU26EN50NGF192N2026-05-28
10887709194486BivonaFT26EN35NGF193N2026-05-28
10887709194509BivonaFT26EN40NGF194N2026-05-28
10887709194226BivonaFT26EN35NSF182N2026-05-27
10887709194233BivonaFU26EN40NGA184N2026-05-27
10887709194240BivonaFT26EN60NSA185N2026-05-27
10887709194356BivonaFT26EN40NSF186N2026-05-27
00887709008045ICU MedicalB33382017-04-17
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194073BivonaHT26ES60NSC163N2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10080196033553MEDLINEMEDLINE INDUSTRIES, INC.BSY2026-05-15
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10080196033331MEDLINEMEDLINE INDUSTRIES, INC.BSY2025-06-12
10080196033348MEDLINEMEDLINE INDUSTRIES, INC.BSY2025-06-12
10080196033362MEDLINEMEDLINE INDUSTRIES, INC.BSY2025-06-12
10080196033355MEDLINEMEDLINE INDUSTRIES, INC.BSY2025-05-29
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
10612479274478McKessonMCKESSON MEDICAL-SURGICAL INC.BSY2025-02-13
10612479274492McKessonMCKESSON MEDICAL-SURGICAL INC.BSY2025-02-13
10612479274515McKessonMCKESSON MEDICAL-SURGICAL INC.BSY2025-02-13
10612479274539McKessonMCKESSON MEDICAL-SURGICAL INC.BSY2025-02-13
10612479274553McKessonMCKESSON MEDICAL-SURGICAL INC.BSY2025-02-13
10612479274577McKessonMCKESSON MEDICAL-SURGICAL INC.BSY2025-02-13
10612479274591McKessonMCKESSON MEDICAL-SURGICAL INC.BSY2025-02-13
10612479274614McKessonMCKESSON MEDICAL-SURGICAL INC.BSY2025-02-13
10192253040166ArgyleCardinal Health 200, LLCBSY2024-08-20
10192253040173ArgyleCardinal Health 200, LLCBSY2024-08-20
10192253042368ArgyleCardinal Health 200, LLCBSY2024-08-20
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13