FDA.reportPublic FDA data

Medisize®

Primary DI
18717146000359
Brand
Medisize®
Company
Medisize B.V.
Model
421 035 015
Device description
Medisize Flexible Catheter Mount 15F/22F
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
BZAConnector, Airway (Extension)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZAConnector, Airway (Extension)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18717146000359PackageGS150Not in Commercial Distribution
28717146000356PackageGS16Not in Commercial Distribution
08717146000352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1871714600035918717146000359
2871714600035628717146000356
08717146000352087171460003528717146000352

GMDN Terms#

Term, Definition table
TermDefinition
Catheter mount, single-useA device used to connect a respiratory circuit (e.g., an anaesthesia breathing circuit or ventilator breathing circuit) or a resuscitator to an endotracheal (ET) tube, to enable increased mobility at the patient end of the circuit or connections. It most commonly consists of a 22 mm female adaptor at the proximal end that is attached to a short length of corrugated, flexible tube (e.g., 150 mm long), and a straight or angled 15 mm male connector at the distal end which may have a suction port included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
407157098
Device count
1
DM exempt
false
Premarket exempt
true
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
00848530109721OXYGEN CONNECTOR/ADAPTERSunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109820Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
00848530109837Ventilation AccessorySunset Healthcare Solutions, Inc.BZA2026-09-09
06923980103629N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980107672N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
06923980111969N/AGaleMed Xiamen Co., Ltd.BZA2026-07-28
04719874957551Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
04719874959197Create BiotechCREATE BIOTECH CO., LTD.BZA2026-07-21
05055931133858Reusable Angle Connector for CBS Bag Arm – Male to MaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
05055931133865Reusable Angle Connector for CBS Bag Arm – Male to FemaleFLEXICARE MEDICAL LIMITEDBZA2026-07-21
10197344012039HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-07-06
10197344214792HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-05-18
10197344009800HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-03-19
10197344012008HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012435HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012466HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012596HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344042326HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2026-01-23
10197344012473HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-12-12
00848530107925Tracheostomy and SuctionSunset Healthcare Solutions, Inc.BZA2025-12-09
00848530098261VENTILATOR ACCESSORYSunset Healthcare Solutions, Inc.BZA2025-08-28
00848530107246Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-08-19
10197344042432HUDSON RCIMEDLINE INDUSTRIES, INC.BZA2025-08-18
10884521854147DARCovidien LPBZA2025-08-10
00848530106317Ventilator CircuitSunset Healthcare Solutions, Inc.BZA2025-07-15
00848530106324Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106331Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530106348Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.BZA2025-07-02
00848530060299Oxygen Connector/AdapterSunset Healthcare Solutions, Inc.BZA2025-06-03
00848530097363Ventilator AccessorySunset Healthcare Solutions, Inc.BZA2025-05-21