FDA.reportPublic FDA data

Thermalite Heated CPAP Tube

Primary DI
00819989011576
Brand
Thermalite Heated CPAP Tube
Company
EXCELERON MEDICAL, INC.
Model
CTUB-06H15DS
Device description
Heated CPAP Tube for DreamStation and DreamStation 2
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241268000Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)Exceleron Medical2024-08-02BZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819989011576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819989011576008199890115768199890115760819989011576

GMDN Terms#

Term, Definition table
TermDefinition
Inspiratory/expiratory limb respiratory tubing, reusableA length of tube made of durable materials (e.g., rubber, silicone) intended to be used to conduct breathing gases towards or away from a patient during the respiratory cycle, typically during anaesthesia or ventilation [including continuous or bi-level positive airway pressure ventilation (CPAP or BPAP)]. It is intended to function as part of a breathing circuit and with other separate gas delivery devices (e.g., respiratory mask, connectors). This is a reusable device intended to be cleaned/disinfected prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825179992
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812970012002NuwaveNW-001NW-0012020-09-23
00812970012019NuwaveNW-002NW-0022020-09-23
00812970012026NuwaveNW-003NW-0032020-09-23
00812970012033NuwaveNW-004NW-0042020-09-23
00812970012040NuwaveUSB-PWR-ADPT-ULUSB-PWR-ADPT-UL2020-09-23
00812970012057NuwaveUSB-PWR-CORDUSB-PWR-CORD2020-09-23
00812970012064NuwaveUSB-PWR-ADPT-KITUSB-PWR-ADPT-KIT2020-09-23
00812970012071NuwaveNUWAVE-BG-SMNUWAVE-BG-SM2020-09-23
00812970012088NuwaveNUWAVE-BG-LGNUWAVE-BG-LG2020-09-23
00812970012095NuwaveCO-001CO-0012020-09-23
00812970012101NuwaveCO-001-KTCO-001-KT2020-09-23
00819989011187CPAP TubingCTUB-018-12021-05-24
00819989011002CPAP TubingCTUB-010-12020-09-24
00819989011026CPAP TubingCTUB-06S-12020-09-23
00819989011040CPAP TubingCTUB-060-12020-09-23
00819989011064CPAP TubingCTUB-080-12020-09-23
00819989011088CPAP TubingCTUB-090-12020-09-23
00819989011101CPAP TubingCTUB-100-12020-09-23
00819989011125CPAP TubingCPAP-TUBE-6FT-SPL-12020-09-23
00819989011149CPAP TubingCTUB-020-12020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881066MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881028ItAllShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-09
00198843003347Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003361Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003385Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003408Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003422Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003545Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003552Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003576Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
04048675824121Seattle PAPDrägerwerk AG & Co. KGaABZD2026-06-11
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04