FDA.reportPublic FDA data

LoFlo

Primary DI
00884838104853
Brand
LoFlo
Company
Respironics Novametrix, LLC
Model
1149474
Catalog number
1149474
Device description
LoFlo CO2 Sampling Cannula ADULT NASAL
Published
2021-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CATCannula, Nasal, Oxygen
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884838104854PackageGS110In Commercial Distribution
00884838104853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088483810485430884838104854
00884838104853008848381048538848381048530884838104853

GMDN Terms#

Term, Definition table
TermDefinition
Carbon-dioxide-sampling nasal oxygen cannulaA non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+7247442500Respironics.Service@philips.com

Regulatory Flags#

DUNS number
093608594
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838104723Airway Adapters114946611494662023-11-15
00884838104730Airway Adapters114933911493392023-11-15
00884838104761Airway Adapters114938111493812023-11-15
00884838104778Airway Adapter114938311493832023-11-15
00884838104785Airway Adapters114938611493862023-11-15
00884838104792Airway Adapters114944811494482023-11-15
00884838104884LoFlo Accessories114948011494802023-11-15
00884838104891LoFlo Accessories114948211494822023-11-15
00884838104907LoFlo Accessories114948311494832023-11-15
00884838104938LoFlo Accessories114937911493792023-11-15
00884838104945LoFlo Accessories114948811494882023-11-15
00884838104952Airway Adapters114948911494892023-11-15
00884838104969Airway Adapters114949011494902023-11-15
00884838104976Airway Adapters114949111494912023-11-15
00884838104983Airway Adapters114949211494922023-11-15
00884838105584Flow Sensor114990311499032023-11-15
00884838105607Flow Sensor114990511499052023-11-15
00884838105614Airway Adapters114994811499482023-11-15
00884838105621Airway Adapters114994211499422023-11-15
00884838104662Capnostat 5 114932111493212023-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10860015046007XChangePneuma Therapeutics, Inc.CCK2026-10-16
00818834029049CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029063CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029087CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029100CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029124CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029148CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029162CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
00818834029186CuraplexTRI-ANIM HEALTH SERVICES, INC.CAT2026-10-15
10885403531521BD Alaris™ ETCO2 Module Model 8300CAREFUSION 303, INC.CCK2026-10-08
00607411917332Salter LabsSALTER LABSCAT2026-10-07
00607411917363Salter LabsSALTER LABSCAT2026-10-07
00607411917394Salter LabsSALTER LABSCAT2026-10-07
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
00840118600361Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118607988Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118609616Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118614900Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617338Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617352Endure IndustriesENDURE INDUSTRIESCAT2026-08-14
00840118617376Endure IndustriesENDURE INDUSTRIESCAT2026-08-14