FDA.reportPublic FDA data

NA

Primary DI
00840682103664
Brand
NA
Company
GE Healthcare Finland Oy
Model
D-lite Spirometry Kit, 3m/10ft
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BZKSpirometer, monitoring (w/wo alarm)
BZLCOMPUTER, OXYGEN-UPTAKE
CAPMONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)
CBQANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)
CBRANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)
CBSANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)
CCLANALYZER, GAS, OXYGEN, GASEOUS-PHASE
NHOAnalyzer, gas, desflurane, gaseous-phase (anesthetic concentration)
NHPAnalyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)
NHQAnalyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2
BZLComputer, Oxygen-UptakeAnesthesiology2
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)Anesthesiology2
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
CBRAnalyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)Anesthesiology2
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Anesthesiology2
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2
NHOAnalyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
NHPAnalyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2
NHQAnalyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051092000DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACCGE Healthcare2005-05-25CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20840682103668PackageGS150In Commercial Distribution
00840682103664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084068210366820840682103668
00840682103664008406821036648406821036640840682103664

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Regulatory Flags#

DUNS number
401966697
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278699923PORTRAIT MMP01MMP015514246-302023-10-26
00195278110435PORTRAIT MMP01MMP0155142462023-09-01
00840682103152TruSignal SpO2TS-F2-GE2016-06-16
00840682147811CARESCAPE Software3.2NA2026-04-15
00195278093998PORTRAIT HUB01HUB012096437-0012023-09-01
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00198953066560NAPiCCO Injectate Sensor Cable2026-01-05
00198953030981PORTRAIT HSWXBV1.25700672-122025-12-10
00840682136402NACardiac Output Cable, 2.4 m/8 ft.2104180-0022018-08-10
00840682102872NAD-lite Spirometry Kit 2m 7ft, 80043812016-08-15
00840682103169TruSignal SpO2TS-F4-MC2016-07-15
00840682103190TruSignal SpO2TS-F4-N2016-06-16
00840682103343TruSignal SpO2TS-F1-H2016-06-16
00840682103367TruSignal SpO2TS-E4-H2016-06-16
00840682103381TruSignal SpO2TS-E4-N2016-06-16
00840682103442NAPre-conf. EEG Lead Set 2 General, 8980512016-06-16
00840682136358NAInvasive Blood Pressure Cable, Argon, Single, 1.2 2104166-0022018-08-10
00840682136365NAInvasive Blood Pressure Cable, Utah/Biotrans, Sing2104107-0022018-08-13
00840682136464NAInvasive Blood Pressure Cable, Utah/Biotrans, Dual2104107-0042018-08-10
00840682136501NAInvasive Blood Pressure Cable, ICU Medical Transpa2104158-0042018-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10889483588635Vital Signs™AirLife Finland OyCCL2025-04-02
10889483588659Vital Signs™AirLife Finland OyCCL2025-03-31
10889483588673Vital Signs™AirLife Finland OyCCL2025-03-31
10889483588697Vital Signs™AirLife Finland OyCCL2025-03-31
10889483587508AirLife™AIRLIFECAP2025-03-13
10889483587515AirLife™AIRLIFECAP2025-03-13
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBQ2024-12-19
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2024-12-19
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBR2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBQ2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBR2024-12-19
90840106905075PERMA PUREPERMA PURE LLCCBQ2024-11-12
90840106905235PERMA PUREPERMA PURE LLCCBQ2024-10-15
00810020360080PERMA PUREPERMA PURE LLCCBQ2024-10-15
10841522127373TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-06-07
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCNHO2024-05-13
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCBQ2024-05-13
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCNHP2024-05-13
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-05-13
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCCL2024-05-13
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCNHQ2024-05-13
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCBS2024-05-13
10841522127366TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCBR2024-04-22
10190752191235Vital Signs™AirLife Finland OyCCL2023-05-30
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCBR2023-04-19
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCCL2023-04-19
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyNHP2023-04-19