FDA.reportPublic FDA data

Portex

Primary DI
35019315121467
Brand
Portex
Company
ICU MEDICAL, INC.
Model
C1105
Published
2015-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BSIAlgesimeter, powered
BTCBAG, RESERVOIR
CAHFilter, bacterial, breathing-circuit
CAICircuit, breathing (w connector, adaptor, y piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSIAlgesimeter, PoweredAnesthesiology2
BTCBag, ReservoirAnesthesiology1
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315121467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931512146735019315121467

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118380146
Device count
1
Kit
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
10887709208145BivonaFF26JN50NGF242N2026-11-02
10887709208152BivonaFT26JN60NGA245N2026-11-02
10887709208169BivonaAT26JS75NSC244N2026-11-02
10887709208176BivonaFT26JN40NSE240N2026-11-02
10887709208183BivonaFT26JN35NSE241N2026-11-02
10887709208190BivonaFT26JN55NGA246N2026-11-02
10887709208220BivonaFT26KN40NGE002N2026-11-02
10887709208237BivonaFT26KN35NGE001N2026-11-02
10887709208244BivonaFU26KN50NGF008N2026-11-02
10887709208251BivonaSA26KN95SSC006N2026-11-02
10887709208268BivonaSU26KN60NSC005N2026-11-02
10887709208275BivonaXA26KS60NSC009N2026-11-02
10887709207902BivonaFT26JN35NGE209S2026-10-30
10887709207933BivonaFU26JN45NSF227N2026-10-30
10887709207940BivonaAT26JS60NSC229N2026-10-30
10887709207957BivonaST26JN45NGF228N2026-10-30
10887709207964BivonaXT26JN50NGC230N2026-10-30
10887709207971BivonaFT26JN50NGC231N2026-10-30
10887709207988BivonaFT26JN50NGC232N2026-10-30
10887709208015BivonaXT26JS55NGF220N2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885632520365HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-30
00848530110086Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-10-27
10885632520341HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-27
10885632520358HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-27
10885632520327HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
10885632520334HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
20885632532129HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
00848530093686Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-10-19
04048675826088VentStar Coax GSL 180Drägerwerk AG & Co. KGaACAI2026-10-15
04048675826316Anesthesia Set Coax GSL 180Drägerwerk AG & Co. KGaACAI2026-10-15
05055931134763FlexicareFLEXICARE MEDICAL LIMITEDCAI2026-10-09
00612649217604ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217628PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217642ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217666ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
B462100053363PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
B462100053393PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
06923980116179N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116186N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116193N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
0503026717028922MM SMOOTHBORE BILEVEL BREATHING SYSTEM FOR NKV-330 WITH MONIT. LINEIntersurgical IncorporatedCAI2026-08-18
14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
10612479284002McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284026McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284040McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284064McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03