FDA.reportPublic FDA data

Disp. humi.chamber f.F&P MR850

Primary DI
04048675422464
Brand
Disp. humi.chamber f.F&P MR850
Company
Drägerwerk AG & Co. KGaA
Model
MP00234
Published
2019-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102618000VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATEDDraeger Medical AG & Co. KG2010-12-10BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048675422464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048675422464040486754224644048675422464

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315578914
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048675542148Evita V80084225002023-06-02
04048675548744Evita V60084223002023-06-02
04048675641308Babyleo TN5002M611002026-03-23
04048675448884Sample Line Set (10pcs)82902862026-02-16
04048675429302Scio Four, Oxi plus68718012015-11-04
04048675034643Connector M34X1.5, 9/162M866802026-02-04
04048675034735"Adapter 9/16"" to 6mm"MP004162026-02-04
04048675229674Apollo86065002015-10-24
04048675429319Scio Four, plus68718022015-11-04
04048675429326Scio Four, Oxi68718032015-11-04
04048675420989APack Watertrap AdultMP016822015-10-24
04048675013532CORRUGATED BELLOWS K84100792015-10-24
04048675010470Corrugated hose 10/10 (N/P) 1984107092015-10-24
04048675022305Hytrel hose 13/13 (N/P) 6584108142015-10-24
04048675041061Headgear disp.,soft rub.,smallMP015612015-10-24
04048675041078Headgear disp.,soft rub.,largeMP015622015-10-24
04048675126317AnesthesiaSet Flex Latexfrei USMP003232015-10-24
04048675253365VentStar Helix dual heatedMP026062015-10-24
04048675253372VentStar Helix heatedMP026072015-10-24
04048675382256Mask ventkit O2Star fixed M/LMP019232015-10-24

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Primary DI, Brand, Company table
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09420012481740F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481795F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481818F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
10197344005994HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-02
10197344009725HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
10197344009596HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-17
10197344009824HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-21
10197344009589HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
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10193489149296HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-11-22
10197344009749HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-10-31
10197344009756HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-09-24
09420012461452F&P Optiflow Junior 2FISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012461469F&P Optiflow Junior 2FISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012476555F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012476579F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012476593F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012477910F&P Optiflow THRIVEFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
10193489149302HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-05-01
10193489149562HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-05-01
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