FDA.reportPublic FDA data

Portex

Primary DI
35019315058855
Brand
Portex
Company
SMITHS MEDICAL ASD, 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
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
137835299
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709142029BivonaST24LN70ZSZ142N2025-02-11
10887709141459BivonaFU24LN35NGF086N2025-01-28
10887709139654BivonaZT24KN80NSC005N2025-01-22
10887709136912BivonaZU24JN80NSC259N2025-01-09
10887709141848BivonaST24LN85NSZ127N2025-01-07
10887709142111BivonaZU24LN40NGF133N2025-01-07
10887709142135BivonaFU24LN50NSZ146N2025-01-07
10887709142234BivonaZU24LN30NSE161N2025-01-07
10887709142241BivonaFT24LN50NGC163N2024-12-19
10887709142258BivonaFU24LN40NSA164N2024-12-19
10887709142265BivonaSU24LN60NSB165N2024-12-19
10887709142272BivonaFU24LN35NSF168N2024-12-19
10887709142289BivonaFT24LN55NSF169N2024-12-19
10887709142296BivonaFT24LN40NSE170N2024-12-19
10887709142302BivonaHT24LS55NSA171N2024-12-19
10887709142319BivonaST24LN90NSC124S2024-12-19
10887709142326BivonaFT24LN40NSE166N2024-12-19
10887709142333BivonaSU24LN40NSB167N2024-12-19
10887709142340BivonaHF24LS90NSB174N2024-12-19
10887709142357BivonaFT24LN55NGF172N2024-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00604351673106MC 300 Reusable NebulizerMonaghan Medical CorporationCAF2026-05-26
44710810080584N/AGALEMED CORPORATIONCAF2026-03-05
44710810082120N/AGALEMED CORPORATIONCAF2026-03-05
44710810082960N/AGALEMED CORPORATIONCAF2026-03-05
44710810084988N/AGALEMED CORPORATIONCAF2026-03-05
44710810085060N/AGALEMED CORPORATIONCAF2026-03-05
44710810085947N/AGALEMED CORPORATIONCAF2026-03-05
44710810086005N/AGALEMED CORPORATIONCAF2026-03-05
44710810088283N/AGALEMED CORPORATIONCAF2026-03-05
44710810088962N/AGALEMED CORPORATIONCAF2026-03-05
44710810089488N/AGALEMED CORPORATIONCAF2026-03-05
44710810110847N/AGALEMED CORPORATIONCAF2026-03-05
44710810112650N/AGALEMED CORPORATIONCAF2026-03-05
20889483230005VixOne™SUNMED, LLCCAF2026-02-11
00199874417059AirpulseAIRPULSE LTDCAF2026-02-03
00810178886371Vive BreatheVIVE HEALTH LLCCAF2026-02-02
00810178884049Vive BreatheVIVE HEALTH LLCCAF2026-01-30
00810178884681Vive BreatheVIVE HEALTH LLCCAF2026-01-30
00810178886814Vive BreatheVIVE HEALTH LLCCAF2026-01-30
04719873130153AdheRespHCMED INNOVATIONS CO., LTD.CAF2026-01-29
04719873130207Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
04719873130214Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
04719873130351Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-28
00848530107932Nebulizer and CompressorSUNSET HEALTHCARE SOLUTIONS, INC.CAF2026-01-26
04719873131228Aerogen® Go HCMED INNOVATIONS CO., LTD.CAF2026-01-22
04719873131235Pulmogine®HCMED INNOVATIONS CO., LTD.CAF2026-01-22
46923980103689N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105430N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105461N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22
46923980105485N/AGaleMed Xiamen Co., Ltd.CAF2026-01-22