FDA.reportPublic FDA data

S10 Heated CPAP Tube

Primary DI
00819989012399
Brand
S10 Heated CPAP Tube
Company
EXCELERON MEDICAL, INC.
Model
CTUB06HS10
Device description
Heated CPAP Tube for ResMed AirSense 10 machines
Published
2026-10-05
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
false

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
00819989012399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819989012399008199890123998199890123990819989012399

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.

Regulatory Flags#

DUNS number
825179992
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
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
00819989011576Thermalite Heated CPAP TubeCTUB-06H15DS2025-01-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814747025017Arie Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025024Arie Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025031Arie Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025048Arie Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025055Ascend Full Face Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025062Ascend Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025079Ascend Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025086Ascend Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025093Arie Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025109Arie Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025116Arie Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025123Arie Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025130Ascend Nasal Vented Mask KitSLEEPNET, CORP.BZD2026-10-23
00814747025147Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025154Ascend Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025161Ascend Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025178IQ 2 Nasal MaskSLEEPNET, CORP.BZD2026-10-23
00814747025185Phantom 2 Nasal Vented MaskSLEEPNET, CORP.BZD2026-10-23
00814747025192MiniMe 2 Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-10-23
00814747025208MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025215MiniMe 2 Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025222MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025314Novaplus Full Face Vented Mask, Extra LargeSLEEPNET, CORP.BZD2026-10-23
00814747025321Novaplus Full Face Vented Mask, LargeSLEEPNET, CORP.BZD2026-10-23
00814747025338Novaplus Full Face Vented Mask, MediumSLEEPNET, CORP.BZD2026-10-23
00814747025345Novaplus Full Face Vented Mask, SmallSLEEPNET, CORP.BZD2026-10-23
00814747025352Novaplus Hospital Nasal Non Vented Mask, m/lSLEEPNET, CORP.BZD2026-10-23
00814747025369Novaplus Hospital Nasal Non Vented Mask, s/mSLEEPNET, CORP.BZD2026-10-23
00814747025376Novaplus Hospital Nasal Vented Mask, m/lSLEEPNET, CORP.BZD2026-10-23
00814747025383Novaplus Hospital Nasal Vented Mask, s/mSLEEPNET, CORP.BZD2026-10-23