FDA.reportPublic FDA data

Portex

Primary DI
10351688429803
Brand
Portex
Company
ICU MEDICAL, INC.
Model
225-3212-700
Published
2016-12-28
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
CBNAPPARATUS, GAS-SCAVENGING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBNApparatus, Gas-ScavengingAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30351688429807PackageGS1100In Commercial Distribution
10351688429803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3035168842980730351688429807
1035168842980310351688429803

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit bag, single-useA non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. It may be made of conductive or non-conductive material and is typically used in anaesthesia or ventilator breathing circuits. 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
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16
10887709198446BivonaHT26GS60NSC097N2026-07-16
10887709198453BivonaHU26GS70NSB104N2026-07-16
10887709198460BivonaSU26GN50NGF113N2026-07-16
10887709198477BivonaFT26GN35NGE112N2026-07-16
10887709198484BivonaAT26GS70NSC096N2026-07-16
10887709198163BivonaFU26GN40NGE068N2026-07-14
10887709198170BivonaFU26GN50NGC069S2026-07-14
10887709198187BivonaFT26GN60NSF067N2026-07-14
10887709198194BivonaSU26GN40NGF073N2026-07-14
10887709198200BivonaFU26GN40NGA064N2026-07-14
10887709198217BivonaFT26GN40NGF074N2026-07-14
10887709198224BivonaFT26GN45SSF075N2026-07-14
10887709198231BivonaFT26GN30NSE076N2026-07-14
10887709198248BivonaFT26GN40NSE077N2026-07-14
10887709198255BivonaFT26GN60NGF078N2026-07-14
10887709198262BivonaFP26GN35ASF079N2026-07-14
10887709198279BivonaFT26GN35NGE080N2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704929419RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
14026704929426RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
14026704929433RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
14026704929440RUSCHTELEFLEX INCORPORATEDCBN2025-10-22
00816711020424NITRONOX SCAVENGERPARKER-HANNIFIN CORPORATIONCBN2025-09-24
00860013652302DemistifierPeace Medical IncCBN2025-08-12
00816711024224SCAVENGER, EAVS, MIDASPARKER-HANNIFIN CORPORATIONCBN2025-02-21
00858545007035SmartProngs CannulaDYNASTHETICS, LLCCBN2024-09-24
00858545007042VeyO2 MaskDYNASTHETICS, LLCCBN2024-09-24
00858545007028SovantDYNASTHETICS, LLCCBN2024-09-24
10858545007032SmartProngs CannulaDYNASTHETICS, LLCCBN2024-09-24
10858545007049VeyO2 MaskDYNASTHETICS, LLCCBN2024-09-24
14026704916648HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
14026704916655HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
24026704916645HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
24026704916652HUDSON RCITELEFLEX INCORPORATEDCBN2024-01-23
00813830021066FRU, Vacuum Connector With BarbsACCUTRON, INC.CBN2023-10-05
00813830022094Accutron Vacuum Male ConnectorACCUTRON, INC.CBN2023-10-05
00813830026856FRU, Axess Vacuum GaugeACCUTRON, INC.CBN2023-10-05
00813830027839FRU, 4 Cylinder Remote Vacuum KitACCUTRON, INC.CBN2023-10-05
00813830027181FRU, Axess Scavenging Control, In-LineACCUTRON, INC.CBN2023-10-02
00813830027327FRU, Axess To Accuvac AdaptorACCUTRON, INC.CBN2023-10-02
00813830027433Axess 90 Deg Outspout ConnectorACCUTRON, INC.CBN2023-10-02
00813830027518White Axess, RFS CircuitACCUTRON, INC.CBN2023-09-21
00813830027525White Axess In-Line CircuitACCUTRON, INC.CBN2023-09-21
00813830027716ClearView Capnography AdaptersACCUTRON, INC.CBN2023-09-14
14026704734198HUDSON RCITELEFLEX INCORPORATEDCBN2023-09-12
14026704734204HUDSON RCITELEFLEX INCORPORATEDCBN2023-09-12
00816711023951SCAVENGER SUB-ASSY,SEN SEDATEPARKER-HANNIFIN CORPORATIONCBN2023-05-17
00863573000408Dynamic Gas Scavenging SystemAnesthetic Gas Reclamation, LLCCBN2023-05-03