FDA.reportPublic FDA data

Portex

Primary DI
35019315110850
Brand
Portex
Company
Smiths Medical International Ltd
Model
C1104
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BTCBAG, RESERVOIR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTCBag, ReservoirAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315110850PackageGS120In Commercial Distribution
15019315110856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931511085035019315110850
1501931511085615019315110856

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient, typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are also devices typically employed in the circuit but may not be a part of this device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215591523
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
30351688423256Portex008430M2015-09-01
30351688423270Portex008430T2015-09-01
30351688423287Portex008431T2015-09-01
30351688424277Portex0084352015-09-01
30351688404002Portex0020002016-10-05
35019517223334PortexC45101816D-NL2020-06-12
35019517236679PortexC45101817D-NL2020-09-18
30351688403036Portex0077672016-10-05
30351688410249Portex0022202016-12-28
30351688410355Portex0077602016-10-05
30351688416128Portex0022232016-12-28
10351688003782Portex5120702015-07-29
30351688005896Portex5630902015-07-29
10351688017949Portex5120902015-07-29
10351688018670Portex5120602015-07-29
10351688018809Portex5121002015-07-29
30351688018858Portex5630802015-07-29
10351688036674Portex5120802015-07-29
30351688036715Portex5631002015-07-29
10351688037176Portex5020602015-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06923980111907MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112614MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112621MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112638MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112805MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
06923980112829MindrayGaleMed Xiamen Co., Ltd.BTC2026-05-26
20889483560959Vital Signs™SUNMED, LLCBTC2025-12-31
20889483560942Vital Signs™SUNMED, LLCBTC2025-12-30
20889483560935Vital Signs™SUNMED, LLCBTC2025-12-19
20885632455435Halyard Breathing BagAIRLIFEBTC2025-07-25
20885632455411Halyard Breathing BagAIRLIFEBTC2025-07-18
20885632455428Halyard Breathing BagAIRLIFEBTC2025-07-18
10889483642412Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642429Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642436Vital Signs Breathing BagAIRLIFEBTC2025-07-18
10889483642443Vital Signs Breathing BagAIRLIFEBTC2025-07-18
20629160000350FEATHER-FLEXBOMImed IncBTC2025-07-14
46923980115552MindrayGaleMed Xiamen Co., Ltd.BTC2025-06-23
10889483602492Vital Signs™AirLife Finland OyBTC2025-04-04
20889483601706Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601713Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601720Vital Signs™AirLife Finland OyBTC2025-04-01
20889483601737Vital Signs™AirLife Finland OyBTC2025-04-01
20889483620073Vital Signs™AirLife Finland OyBTC2025-04-01
20889483602505Vital Signs™AirLife Finland OyBTC2025-03-28
20889483602512Vital Signs™AirLife Finland OyBTC2025-03-28
30889483584808Vital Signs™Sunmed Group Holdings, LLCBTC2025-03-06
30889483584822Vital Signs™Sunmed Group Holdings, LLCBTC2025-03-06
06972249260085Breathing bagsShandong Jinlai Huanhai Medical Technology Co., Ltd.BTC2025-03-03
06972249260092Breathing bagsShandong Jinlai Huanhai Medical Technology Co., Ltd.BTC2025-03-03