FDA.reportPublic FDA data

Heated Breathing Set

Primary DI
00860009312296
Brand
Heated Breathing Set
Company
Telesair, Inc.
Model
HBCK01
Device description
Contains:(1) Breathing Circuit(1) Water Chamber(1) Water Chamber Adaptor
Published
2025-03-12
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
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860009312293PackageGS110In Commercial Distribution
00860009312296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000931229310860009312293
00860009312296008600093122968600093122960860009312296

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117854209
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
00860009312234Bonhawa Air FilterAF2025-03-14
00860009312265Adult Nasal Cannula, Small ENC032025-03-12
00860009312272Adult Nasal Cannula, MediumENC022025-03-12
00860009312289Adult Nasal Cannula, LargeENC012025-03-12
00850057298000Bonhawa Respiratory HumidifierRHFG3032025-03-12
10860009312262Adult Nasal Cannula, Small ENC032025-03-12
10860009312279Adult Nasal Cannula, MediumENC022025-03-12
10860009312286Adult Nasal Cannula, LargeENC012025-03-12

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