FDA.reportPublic FDA data

HME 10 Basic

Primary DI
30734000671342
Brand
HME 10 Basic
Company
Pharma Systems Ps AB
Model
6060
Catalog number
6060
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
30734000671342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3073400067134230734000671342

GMDN Terms#

Term, Definition table
TermDefinition
Electrocautery system generator, line-poweredA mains electricity (AC-powered) device that regulates an electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.3Centimeter

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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Primary DI, Brand, Company table
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08904428745067OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
10884389976067MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
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10889483571590AirLife™AIRLIFEBYD2025-02-21
10889483571637AirLife™AIRLIFEBYD2025-02-21
10889483571644AirLife™AIRLIFEBYD2025-02-21
10889483334577AirLife™AIRLIFEBYD2025-02-20
10889483571545AirLife™AIRLIFEBYD2025-02-20
10889483571569AirLife™AIRLIFEBYD2025-02-20
10889483571613AirLife™AIRLIFEBYD2025-02-20
10889483571620AirLife™AIRLIFEBYD2025-02-20
10859760005056Passy Muir PASSY-MUIR, INC.BYD2025-02-03
10810050855621ThermoFlo®TYPENEX MEDICAL LLCBYD2024-11-14
10193489024647MedlineMEDLINE INDUSTRIES, INC.BYD2024-03-05
10850014574793HME FlexPEPPER MEDICAL INC.BYD2023-10-25
10884521082502DARCovidien LPBYD2023-09-16
10884521829060DARCovidien LPBYD2023-09-16
10884521829152DARCovidien LPBYD2023-09-16
10884521829183DARCovidien LPBYD2023-09-16
10884521829190DARCovidien LPBYD2023-09-16
10884521829206DARCovidien LPBYD2023-09-16
10884521829213DARCovidien LPBYD2023-09-16
10884521829220DARCovidien LPBYD2023-09-16
10884521829176DARCovidien LPBYD2023-09-01
10888277702202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BYD2023-01-26
10840330700181ProcureTwin Med, LLCBYD2022-11-02
10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05