FDA.reportPublic FDA data

Airway Adapters

Primary DI
00884838104792
Brand
Airway Adapters
Company
Respironics Novametrix, LLC
Model
1149448
Catalog number
1149448
Device description
Neonatal/Pediatric Airway Adapter
Published
2023-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZACONNECTOR, AIRWAY (EXTENSION)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884838104793PackageGS110In Commercial Distribution
00884838104792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088483810479330884838104793
00884838104792008848381047928848381047920884838104792

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide cuvette, single-useA device intended to be used with a mainstream carbon dioxide (CO2) sensor for the determination of CO2 concentration in gases expired from a patient. It is designed as a small, plastic, open-ended vessel with a clear optic window (cuvette) for the acceptance of an infrared sensor that is slotted over the outside of the window section. It typically has connector ports that enable it to be connected into a breathing system (e.g., an anaesthesia or critical care ventilation system). 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-10 Degrees Celsius55 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(724)744-2500Respironics.Service@philips.com

Regulatory Flags#

DUNS number
093608594
Device count
1
DM exempt
true
Premarket 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
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
00884838104679Capnostat 5 114933511493352023-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344214792HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-05-18
10197344009800HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
10197344012008HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012466HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012596HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344042326HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10889483225257AirLife™SUNMED, LLCBZA2025-12-22
10889483225226Adapters/ConnectorsSUNMED, LLCBZA2025-12-18
10889483225271AirLife™SUNMED, LLCBZA2025-12-18
10889483225660AirLife™SUNMED, LLCBZA2025-12-18
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
10884521084995DARCovidien LPBZA2025-04-12
10884521842533DARCovidien LPBZA2025-04-12
10884522019743DARCovidien LPBZA2025-04-12
10884522019750DARCovidien LPBZA2025-04-12
10884522019774DARCovidien LPBZA2025-04-12
10884522019781DARCovidien LPBZA2025-04-12
10884522019804DARCovidien LPBZA2025-04-12
10884522019811DARCovidien LPBZA2025-04-12
10884522019828DARCovidien LPBZA2025-04-12
10884522019835DARCovidien LPBZA2025-04-12
10884522019842DARCovidien LPBZA2025-04-12
10884522019859DARCovidien LPBZA2025-04-12
10884522019866DARCovidien LPBZA2025-04-12
10884522019873DARCovidien LPBZA2025-04-12
10884522019880DARCovidien LPBZA2025-04-12
10884522019897DARCovidien LPBZA2025-04-12