Create Biotech

Primary DI
04719874955939
Brand
Create Biotech
Company
CREATE BIOTECH CO., LTD.
Model
003-011-001
Device description
Heat and Moisture Exchange
Published
2026-07-16
Public version status
New
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
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
04719874955939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719874955939047198749559394719874955939

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.

Regulatory Flags#

DUNS number
656387282
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719874951467Create Biotech003-009-0012026-07-16
04719874951504Create Biotech005-001-0302026-07-16
04719874954611Create Biotech015-111-0122026-07-16
04719874956547Create Biotech010-001-10642026-07-16
04719874956554Create Biotech010-001-10652026-07-16
04719874957568Create Biotech021-004-0360-12026-07-16
04719874957575Create Biotech008-016-10502026-07-16
04719874957667Create Biotech021-005-0082026-07-16
04719874958459Create Biotech021-008-0082026-07-16
04719874958503Create Biotech021-004-02002026-07-16

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Primary DI, Brand, Company table
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08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
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