FDA.reportPublic FDA data

Portex

Primary DI
10351688402646
Brand
Portex
Company
ICU MEDICAL, INC.
Model
008012
Published
2015-10-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTMVentilator, emergency, manual (resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTMVentilator, Emergency, Manual (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952169000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952169000SAFE RESPONSE MOUTH-TO-MASK RESUSCITATOR, PEDIATRICIntertech Resources, Inc.1995-06-08BTM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30351688402640PackageGS110Not in Commercial Distribution
10351688402646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3035168840264030351688402640
1035168840264610351688402646

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Sterilization Methods#

Method table
Method

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
10887709198385BivonaXZ26GS70NSC058N2026-08-03
10887709198866BivonaFU26GN40NSZ134N2026-08-03
10887709198880BivonaXU26GS55NGZ141N2026-08-03
10887709199368BivonaZT26GN95ZSZ155N2026-08-03
10887709199580BivonaFT26GN45NSE190N2026-08-03
10887709199641BivonaSA26GN80ZSZ135N2026-08-03
10887709199764BivonaXU26GS60NSA218N2026-08-03
10887709199771BivonaFU26GN55NSF216N2026-08-03
10887709199788BivonaXU26GS60NSA217N2026-08-03
10887709199801BivonaFU25GN65NSD167N2026-08-03
10887709199818BivonaSU26GN50NGF219N2026-08-03
10887709199825BivonaFU26GN45NSC211N2026-08-03
10887709199832BivonaFU26GN45NGF214N2026-08-03
10887709199849BivonaFU26GN35NSE226N2026-08-03
10887709199856BivonaFU26GN30NSE227N2026-08-03
10887709199863BivonaFT26GN40NSC233N2026-08-03
10887709200002BivonaFU26GN45NSF240N2026-08-03
10887709200019BivonaFT26GN55NGF246N2026-08-03
10887709200026BivonaFU26GN30NGA239N2026-08-03
10887709200033BivonaST26GN55NSC245N2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344097395MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097401MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097418MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097425MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097432MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344097449MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100446MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100453MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100477MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100484MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344110902MEDLINEMEDLINE INDUSTRIES, INC.BTM2025-06-13
10197344100460MEDLINEMEDLINE INDUSTRIES, INC.BTM2024-12-05
10195327558598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BTM2023-12-21
10193489139303MedlineMEDLINE INDUSTRIES, INC.BTM2023-02-04
10193489189162MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
10193489189179MedlineMEDLINE INDUSTRIES, INC.BTM2023-01-27
00840117326002RespO2 Manual Pulmonary Resuscitator (MPR)Dynarex CorporationBTM2023-01-09
10193489181937MedlineMEDLINE INDUSTRIES, INC.BTM2022-11-10
10080196659777MedlineMEDLINE INDUSTRIES, INC.BTM2022-10-28
10193489003123MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-22
10193489092400MedlineMEDLINE INDUSTRIES, INC.BTM2022-07-12
10193489001945MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489001952MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
10193489009767MedlineMEDLINE INDUSTRIES, INC.BTM2022-06-10
06946430410856CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
06946430410870CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTM2021-09-15
10193489001150MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489001167MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489003116MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14
10193489003758MedlineMEDLINE INDUSTRIES, INC.BTM2021-07-14