FDA.reportPublic FDA data

Portex

Primary DI
15019315010989
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/465/060
Published
2015-09-01
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
BWCNeedle, emergency airway

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWCNeedle, Emergency AirwayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315010983PackageGS11In Commercial Distribution
55019315010987PackageGS110In Commercial Distribution
15019315010989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931501098335019315010983
5501931501098755019315010987
1501931501098915019315010989

GMDN Terms#

Term, Definition table
TermDefinition
Cricothyrotomy kit, single-useA collection of sterile devices designed to perform a cricothyrotomy (an incision through the skin and cricothyroid) providing airway access within seconds allowing for immediate ventilation of the patient and necessary suction procedures. It is used to open a patient's airway in emergency interventions, e.g., accidental blockage to the upper airway tract, and prior to tracheostomy. 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
10887709194899BivonaFU26FN35NGE024N2026-06-04
10887709194905BivonaFT26FN40NGE027N2026-06-04
10887709194912BivonaFU26FN40NGE028N2026-06-04
10887709194929BivonaXT26FS50NSF019N2026-06-04
10887709194936BivonaFT26EN40NSF122S2026-06-04
10887709194943BivonaFT26EN40NSF122S2026-06-04
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250105630770ScalpelCricVBM Medizintechnik GmbHBWC2026-05-08
04250105629736ScalpelCricVBM Medizintechnik GmbHBWC2022-12-21
04250105628111n.a.VBM Medizintechnik GmbHBWC2020-11-09
14250105628118n.a.VBM Medizintechnik GmbHBWC2020-11-09
15019315110528PortexICU MEDICAL, INC.BWC2017-05-29
35019315110522PortexICU MEDICAL, INC.BWC2017-05-29
00827002077966PatilCOOK INCORPORATEDBWC2015-10-24
00827002082519ArndtCOOK INCORPORATEDBWC2015-10-24
00827002089501PatilCOOK INCORPORATEDBWC2015-10-24
00827002094130CookCOOK INCORPORATEDBWC2015-10-24
00827002103382CookCOOK INCORPORATEDBWC2015-10-24
04026704111671RUSCHTELEFLEX INCORPORATEDBWC2015-10-16