FDA.reportPublic FDA data

NA

Primary DI
20840682102920
Brand
NA
Company
GE Healthcare Finland Oy
Model
Mini D-fend Water Trap, 8002174
Published
2016-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZKSpirometer, monitoring (w/wo alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZKSpirometer, Monitoring (W/Wo Alarm)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051092000
K052582000

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
K052582000DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIESGE Healthcare2005-10-14CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20840682102920PackageGS110In Commercial Distribution
00840682102926PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084068210292020840682102920
00840682102926008406821029268406821029260840682102926

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit condensate trap, reusableA non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent the leak of fluid when removed from the circuit; it does not include a moisture filter. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)558-5120xx@xx.xx

Regulatory Flags#

DUNS number
401966697
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
false
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
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
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyBZK2026-04-15
00851540007161ExSpiron Pediatric PadSetsSenzime AB (Publ.)BZK2024-01-25
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05065016557011KoKoKOKO PFT LTDBZK2023-08-01
05065016557028KoKoKOKO PFT LTDBZK2023-08-01
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBZK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyBZK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyBZK2023-04-19
00195278524089NAGE Healthcare Finland OyBZK2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyBZK2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyBZK2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyBZK2022-05-13
00840682104135NAGE Healthcare Finland OyBZK2022-03-07
00840682104302NAGE Healthcare Finland OyBZK2022-03-07
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