FDA.reportPublic FDA data

XChange

Primary DI
10860015046014
Brand
XChange
Company
Pneuma Therapeutics, Inc.
Model
PX-XCS-20
Device description
XChange™ Oxygen Therapy Positive Pressure Interface with Integrated End-Tidal CO2, Sampling (Case of 20)
Published
2026-11-02
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
BSJMask, Gas, Anesthetic
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
NHKResuscitator, Manual, Non Self-Inflating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSJMask, Gas, AnestheticAnesthesiology1
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
NHKResuscitator, Manual, Non Self-InflatingAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001714000
K210112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001714000MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149Mercury Medical2000-11-03NHK
K210112000XChange Device, XChange SystemPneuma Therapeutics, Inc.2023-01-30CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860015046014PrimaryGS10
00860015046017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001504601410860015046014
00860015046017008600150460178600150460170860015046017

Regulatory Flags#

DUNS number
144851876
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
10860015046007XChangePX-XC-202026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049098058018Infinity MCable - Microstream CO2DRAEGER MEDICAL SYSTEMS, INC.CCK2026-10-30
04049098061131MCable Microstream CO2 KitDRAEGER MEDICAL SYSTEMS, INC.CCK2026-10-30
10860015046007XChangePneuma Therapeutics, Inc.CCK2026-10-16
10860015046007XChangePneuma Therapeutics, Inc.BSJ2026-10-16
10885403531521BD Alaris™ ETCO2 Module Model 8300CAREFUSION 303, INC.CCK2026-10-08
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyCCK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyCCK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyCCK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyCCK2026-10-04
10889483618264Air LifeAIRLIFECCK2026-08-26
10889483618271Air LifeAIRLIFECCK2026-08-26
10889483618288Air LifeAIRLIFECCK2026-08-26
10889483618295Air LifeAIRLIFECCK2026-08-26
10889483618301Air LifeAIRLIFECCK2026-08-26
10889483618318Air LifeAIRLIFECCK2026-08-26
00199972000474CuraplexBOUND TREE MEDICAL, LLCCCK2026-08-15
00840118623681Endure IndustriesENDURE INDUSTRIESBSJ2026-08-14
06946430427496CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427519CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427533CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427557CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427571CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427595CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
06946430427618CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBSJ2026-08-08
00884400815477VisubreathAFFIRM MEDICAL TECHNOLOGIES II, LLCCCK2026-08-05
00607411946684Salter LabsSALTER LABSCCK2026-08-03
00607411961342N/ASALTER LABSCCK2026-08-03
14026704665010HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665188HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01
14026704665218HUDSON RCITELEFLEX INCORPORATEDBSJ2026-08-01