FDA.reportPublic FDA data

Breathing set, unheated

Primary DI
04055146499634
Brand
Breathing set, unheated
Company
WILAmed GmbH
Model
BTS2259
Catalog number
271757
Published
2026-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055147000105PackageGS110In Commercial Distribution
04055146499634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055147000105040551470001054055147000105
04055146499634040551464996344055146499634

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
342827867
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055146499122Breathing set, unheatedBTS60532716782026-10-20
04055146499146Breathing set, unheatedBTS80722716792026-10-20
04055146499467Breathing set, unheatedBTS60732717322026-10-20
04055146499474Breathing set, unheatedBTS81162717332026-10-20
04055146499481Breathing set, unheatedBTS60742717342026-10-20
04055146499498Breathing set, unheatedBTS81182717372026-10-20
04055147001393Breathing set, unheatedBTS60912717882026-10-20
04055147001409Breathing set, unheatedBTS81672717892026-10-20
04055146040935Breathing set, unheatedBTS3002710032026-10-19
04055146040232CLEARlineBTS8342711912026-08-03
04055146040843CLEARlineBTS33012709312026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055146499122Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499146Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499467Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499474Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499481Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146499498Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001393Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055147001409Breathing set, unheatedWILAmed GmbHBZO2026-10-20
04055146040935Breathing set, unheatedWILAmed GmbHBZO2026-10-19
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