FDA.reportPublic FDA data

HME HumidStar 55 Plus

Primary DI
04048675665663
Brand
HME HumidStar 55 Plus
Company
Drägerwerk AG & Co. KGaA
Model
MP05730
Published
2022-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04048675665663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675665663040486756656634048675665663

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315578914
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675824121Seattle PAPMP022542026-06-11
04048675251422Savina 30084178002015-10-24
04048675542148Evita V80084225002023-06-02
04048675548744Evita V60084223002023-06-02
04048675641308Babyleo TN5002M611002026-03-23
04048675448884Sample Line Set (10pcs)82902862026-02-16
04048675429302Scio Four, Oxi plus68718012015-11-04
04048675034643Connector M34X1.5, 9/162M866802026-02-04
04048675034735"Adapter 9/16"" to 6mm"MP004162026-02-04
04048675229674Apollo86065002015-10-24
04048675429319Scio Four, plus68718022015-11-04
04048675429326Scio Four, Oxi68718032015-11-04
04048675420989APack Watertrap AdultMP016822015-10-24
04048675013532CORRUGATED BELLOWS K84100792015-10-24
04048675010470Corrugated hose 10/10 (N/P) 1984107092015-10-24
04048675022305Hytrel hose 13/13 (N/P) 6584108142015-10-24
04048675041061Headgear disp.,soft rub.,smallMP015612015-10-24
04048675041078Headgear disp.,soft rub.,largeMP015622015-10-24
04048675126317AnesthesiaSet Flex Latexfrei USMP003232015-10-24
04048675253365VentStar Helix dual heatedMP026062015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874951467Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
04719874955939Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
08904428744916OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
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
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
10884521829176DARCovidien LPBYD2023-09-01
07331791008320HME DigiTop O2Atos Medical ABBYD2022-12-07
07331791015564Provox Life Coming Home USAAtos Medical ABBYD2022-11-29
10840330700181ProcureTwin Med, LLCBYD2022-11-02
10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752105928AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752141964AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752141988AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752139794AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139800AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139817AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139824AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139831AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139992AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10193489139983MedlineMEDLINE INDUSTRIES, INC.BYD2022-08-04
10193489331172Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BYD2022-08-04