FDA.reportPublic FDA data

Portex

Primary DI
15019315071393
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/322/060
Published
2020-02-12
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
CAEAIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315071397PackageGS110In Commercial Distribution
55019315071391PackageGS110In Commercial Distribution
15019315071393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931507139735019315071397
5501931507139155019315071391
1501931507139315019315071393

GMDN Terms#

Term, Definition table
TermDefinition
Oropharyngeal airway, single-useA curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use 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
10887709197272BivonaFT26FN70NSZ233N2026-07-23
10887709198392BivonaSU26GN80NZC083N2026-07-23
10887709198408BivonaZA26GN85NSC085N2026-07-23
10887709198750BivonaSZ26GN70ZSZ114N2026-07-23
10887709198873BivonaZU26GN75NSC099N2026-07-23
10887709198941BivonaZU26GN60NGF143N2026-07-23
10887709198958BivonaZU26GN55NGF144N2026-07-23
10887709199085BivonaFU26GN35NGF169N2026-07-23
10887709199092BivonaFT26GN35NGA089N2026-07-23
10887709199108BivonaFT26GN35NGE166N2026-07-23
10887709199115BivonaST26GN40NGF165N2026-07-23
10887709199146BivonaFT26GN55NGC172N2026-07-23
10887709199153BivonaFU26GN55NGC170N2026-07-23
10887709199160BivonaFT26GN50NGC171N2026-07-23
10887709199177BivonaFU26GN40NGA178N2026-07-23
10887709199184BivonaFU26GN55NSF173N2026-07-23
10887709199207BivonaST26GN50NSC177N2026-07-23
10887709199214BivonaFT26GN30NGF174N2026-07-23
10887709199221BivonaST26GN55NSC176N2026-07-23
10887709199238BivonaFT26GN40NGE175N2026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704624697RUSCHTELEFLEX INCORPORATEDCAE2026-07-22
04719874951504Create BiotechCREATE BIOTECH CO., LTD.CAE2026-07-16
04719874957575Create BiotechCREATE BIOTECH CO., LTD.CAE2026-07-16
15060112315029LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-06-24
15060112315036LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-06-24
15060112315043LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-06-24
05030267169870I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169894I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.0, SMALL PAEDIATRIC, 10-25KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169917I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169931I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169955I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169979I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.5, INFANT, 5-12KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169993I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.5, LARGE PAEDIATRIC, 25-35KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170012I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170036I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170050I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)Intersurgical IncorporatedCAE2026-06-02
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmASSOMEDIKA, OOOCAE2026-05-27
10197344165605MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165612MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165629MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165636MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165643MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165650MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165667MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165674MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10801902154054LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902154061LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902154078LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11