FDA.reportPublic FDA data

Medisize®

Primary DI
28717146000400
Brand
Medisize®
Company
Medisize B.V.
Model
356 001 010B
Device description
Medisize Gold Comfort
Published
2016-10-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18717146000403PackageGS125Not in Commercial Distribution
28717146000400PackageGS14Not in Commercial Distribution
08717146000406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1871714600040318717146000403
2871714600040028717146000400
08717146000406087171460004068717146000406

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger insertable filterA dedicated membrane that is inserted into a reusable heat & moisture exchanger (HME) to capture a patient's exhaled heat and moisture, so that they can be used to heat and humidify therapeutic gases inspired by the patient typically during anaesthesia or intensive care ventilation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
407157098
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717146000208Medisize®433 001 0002016-10-07
08717146000215Medisize®433 001 0102016-10-07
08717146000222Medisize®433 005 0102016-10-07
08717146000352Medisize®421 035 0152016-10-07
08717146000369Medisize®423 005 0102016-10-07
08717146009805Medisize®453 005 0002016-10-07
08717146000239Medisize®501 003 1202016-10-07
08717146000246Medisize®501 003 1502016-10-07
08717146000253Medisize®501 003 1802016-10-07
08717146000260Medisize®501 003 2102016-10-07
08717146000277Medisize®550 003 1202016-10-07
08717146000284Medisize®550 003 1502016-10-07
08717146000291Medisize®550 003 1802016-10-07
08717146000307Medisize®550 003 2102016-10-07
08717146000314Medisize®552 003 1202016-10-07
08717146000321Medisize®552 003 1502016-10-07
08717146000338Medisize®552 003 1802016-10-07
08717146000345Medisize®552 003 2102016-10-07
08717146000017Medisize®303 100 0002016-10-07
08717146000024Medisize®303 200 0002016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344016884HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016891HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016938HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016945HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016969HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016976HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016983HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
00841737100775Vapotherm Inc.VAPOTHERM, INC.BTT2026-06-23
09420012425911Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
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00810083350561SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
10889483570906AirLife™AIRLIFEBTT2025-02-20
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10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 mlAIRLIFEBTT2025-02-20
10197344009749HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-10-31
10197344009756HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-09-24
07640140860749Monsoon III Laserjet 70Acutronic Medical Systems AGBTT2023-01-20
00810071637285CuraplexBOUND TREE MEDICAL, LLCBTT2022-12-30
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00810071637308CuraplexBOUND TREE MEDICAL, LLCBTT2022-12-30
09420012416179Fisher and Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012428493F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429117F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429155F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429711F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429735F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02