FDA.reportPublic FDA data

Smart CapnoLine / Microstream

Primary DI
20884838071081
Brand
Smart CapnoLine / Microstream
Company
Philips Medical Systems Hsg
Model
Smart CapnoLine H O2 Pediatric Long
Catalog number
989803177981
Device description
Smart CapnoLine: Oral/Nasal, CO2/O2, Pediatric, long term, 4m
Published
2017-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884838071081PrimaryGS10
00884838071087Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088483807108120884838071081
00884838071087008848380710878848380710870884838071087

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
790605856
Device count
25
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884838071074Smart CapnoLine / MicrostreamSmart CapnoLine H 02 Pediatric9898031779712017-08-23
20884838071111FilterLine / MicrostreamNasal FilterLine Infant/Neonatal9898031780212017-08-23
20884838071180VitaLine / MicrostreamTrade Compliant:VitaLineH Set, Adult/Ped9898031829412017-09-26
20884838071265Smart CapnoLine / MicrostreamSmart Capnoline Guardian O2 Long9898031830012017-03-29
20884838071494NIV Line/MicrostreamNIV Line / Pediatric9898031316512017-07-10
20884838071517CapnoLine/MicrostreamCapnoLine H / Infant/Neonatal9898031316812017-08-23
00884838089655Temperature ProbesE/R Temp Probe 12 FR Reuse Autoclavable9898032035612023-09-18
00884838089679Temperature ProbesSkin Temp Probe Reusable Autoclavable9898032035812023-09-18
20884838091836Microstream Advance Adult-Pediatric Intubated CO2 Filter LineAdt/Pedi Intub CO2 Line LTerm9898032045212021-07-23
00884838000476DigiTrak XTDigiTrak XT Holter Recorder8603222016-11-21
00884838048089Philips12-Lead Patient Cable (AAMI), Std Length9898031849312023-05-25
00884838048102Philips12-Lead Patient Cable (AAMI), Long9898031849512023-05-25
00884838012974NOUNPW CBL Complete Lead Set AAMI9898031516312016-12-06
00884838012981NOUNPW CBL Complete Lead Set IEC9898031516412016-12-06
00884838012998NOUNChest Lead Set, AAMI/IEC9898031516712016-12-06
00884838013001NOUNLong Chest Lead Set (Both AAMI and IEC)9898031516912016-11-11
00884838013025NOUNLimb Lead Set (Both AAMI and IEC)9898031517112016-11-03
00884838013032NOUNLong Limb Lead Set (Both AAMI and IEC)9898031517312017-06-07
00884838013049NOUNTC ADDITIONAL LEADS KIT: AAMI9898031517512017-05-11
00884838013056NOUNTC ADDITIONAL LEADS KIT: IEC9898031517612017-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860015046014XChangePneuma Therapeutics, Inc.CCK2026-11-02
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
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
00884400815477VisubreathAFFIRM MEDICAL TECHNOLOGIES II, LLCCCK2026-08-05
00607411946684Salter LabsSALTER LABSCCK2026-08-03
00607411961342N/ASALTER LABSCCK2026-08-03
00607411947124N/ASALTER LABSCCK2026-07-28
00607411947131N/ASALTER LABSCCK2026-07-28
00607411947162N/ASALTER LABSCCK2026-07-28
04048675795124Sample Line 2,5mDrägerwerk AG & Co. KGaACCK2026-07-21
04048675723677Vista 300 Sidestream CO2 ModuleShanghai Draeger Medical Instrument Co.,Ltd.CCK2026-07-13
00607411919190Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919213Salter Labs® Nasal CannulaSALTER LABSCCK2026-06-10
00607411919206MedTronic ETCo2 CannulaSALTER LABSCCK2026-06-09
10884521858077NellcorCovidien LPCCK2026-05-29
10884521858084NellcorCovidien LPCCK2026-05-29
10884521858091NellcorCovidien LPCCK2026-05-29