FDA.reportPublic FDA data

Pharma Trach HME Pack Oxygen Port

Primary DI
30734000672035
Brand
Pharma Trach HME Pack Oxygen Port
Company
Pharma Systems Ps AB
Model
6251
Catalog number
6251
Device description
HME
Published
2023-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYDCONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30734000672035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3073400067203530734000672035

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-use"A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an ""artificial nose"", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device."

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.2Centimeter

Contacts#

Phone, Email table
PhoneEmail
+4618349500info@pharmasys.se

Regulatory Flags#

DUNS number
356335752
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
30734000671007Bact-HME Basic600060002023-10-24
30734000671076Bact-HME Port602060202023-10-24
30734000671182Pharma Mini Basic610061002023-10-24
30734000671243Pharma Mini Port612061202023-10-24
30734000671267Pharma Mini Port Angle613061302023-10-24
30734000671434Bact-Trap Basic701070102023-10-24
30734000671441Bact-Trap Port701170112023-10-24
30734000671540Bact-Trap Mini Basic705070502023-10-24
30734000671564Bact-Trap Mini Port705570552023-10-24
30734000671588Bact-Trap Mini Port Angle706170612023-10-24
30734000671946Bact-HME Midi Port631063102023-10-24
30734000671953Bact-HME Midi Port Angle632063202023-10-24
30734000671960Bact-Trap Midi Port711071102023-10-24
30734000671977Bact-Trap Midi Port Angle712071202023-10-24
30734000672189Pharma Mini Port 2612161212023-10-24
30734000672196Bact-Trap Mini Port 2705470542023-10-24
30734000672202Pharma Mini Port 2 Elbow612661262023-10-24
30734000672318Bact-HME 1/2 Basic6000H6000H2023-10-24
30734000672325Bact-HME 1/2 Port6020H6020H2023-10-24
30734000672332Bact-HME Midi 1/2 Port6310H6310H2023-10-24

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10840330700181ProcureTwin Med, LLCBYD2022-11-02
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