FDA.report

etCO2 Airway Adaptor - Sidestream

Primary DI
04049098009195
Brand
etCO2 Airway Adaptor - Sidestream
Company
DRAEGER MEDICAL SYSTEMS, INC.
Model
4714437
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications

CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049098009195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049098009195040490980091954049098009195

GMDN Terms

TermDefinition
Carbon dioxide cuvette, reusableA 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 typically 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 reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+18004372437info@draeger.com

Regulatory Flags

DUNS number
788289952
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04049098041829Disposable Mechanical Ventilation CircuitMU047712025-12-10
04048675673408Gateway Software Server VF9.0.1MS405452025-02-19
04048675762256Gateway Software Server VF9.1.137347182025-02-19
04048675777762Gateway Software Server VF9.1.237363762025-02-19
04048675780212Infinity R50-S RecorderMS412172025-02-19
04049098001519Infinity M300 Bedside ChargerMS295582025-02-19
04049098007061Infinity Gateway USB DongleMS117002025-02-19
04049098095730Infinity M300+MS339502025-02-19
04049098095778SHIP UNIT M300+MS336482025-02-19
04049098096423SHP EXC M300+MS336592025-02-19
04049098099264S/W SUB VF9.0 GatewayMS400462025-02-19
04049098099608Gateway Software Server VF9.0MS400482025-02-19
04049098099042Babyroo TN300 Infant Radiant WarmerMU203002023-06-08
04049098002035 INFINITY M300 Nellcor WPA2 MS260762015-10-24
04049098002066Infinity M300 Masimo WPA2 MS260312015-10-24
04049098002172Omega-S SolutionMS254902015-11-02
04049098003858Infinity Vista XL MonitorMS189862015-10-24
04049098003865INFINITY GAMMMA XLMS189852015-10-24
04049098004022Vista MonitorMS188542015-10-24
04049098004039Infinity Kappa MonitorMS188532015-10-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20889483226435Bell Medical CannulaSALTER LABSCCK2026-03-13
04048675448884Sample Line Set (10pcs)Drägerwerk AG & Co. KGaACCK2026-02-16
20889483230555AirLife™SUNMED, LLCCCK2025-12-31
20889483221157AirLife™SUNMED, LLCCCK2025-12-18
20889483222390AirLife™SUNMED, LLCCCK2025-12-18
20889483230364AirLife™SUNMED, LLCCCK2025-12-18
10885403520761BD Alaris™ ETCO2 Module, Model 8300CAREFUSION 303, INC.CCK2025-09-10
15055140702804MediplusMEDIPLUS LTDCCK2025-08-29
00810094579562Curaplex®BOUND TREE MEDICAL, LLCCCK2025-08-06
00810094579579Curaplex®BOUND TREE MEDICAL, LLCCCK2025-08-06
30889483236325Iradimed Adult Capnography CannulaSALTER LABSCCK2025-08-04
30889483236332Iradimed Infant Capnography CannulaSALTER LABSCCK2025-08-04
30889483236349Iradimed Pediatric Capnography CannulaSALTER LABSCCK2025-08-04
30889483236356IradimedSALTER LABSCCK2025-08-04
30889483236363IradimedSALTER LABSCCK2025-08-04
30889483236370IradimedSALTER LABSCCK2025-08-04
30889483236387IradimedSALTER LABSCCK2025-08-04
30889483236318Iradimed Sample Line ExtensionSALTER LABSCCK2025-08-04
09555866300876DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2025-08-01
20885632455442Halyard Gas Sampling LineAIRLIFECCK2025-07-25
10885632455452Halyard Gas Sampling LineAIRLIFECCK2025-07-25
20888277420592MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-06-13
00840117342361Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) O2 and CO2 TubingDynarex CorporationCCK2025-06-09
00840117342385Resp-O2 EtCO2 Nasal Sampling Cannula, 14" (4.2 m ) O2 and CO2 Tubing Dynarex CorporationCCK2025-06-09
00840117342408Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) O2 and CO2Dynarex CorporationCCK2025-06-09
20884389815318MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-25
20884389815066MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-24
20889483600501Vital Signs™AirLife Finland OyCCK2025-04-02
00843997016544NomolineMASIMO CORPORATIONCCK2025-04-01
20889483600518Vital Signs™AirLife Finland OyCCK2025-03-31