FDA.reportPublic FDA data

Medisize®

Primary DI
28717146000332
Brand
Medisize®
Company
Medisize B.V.
Model
552 003 180
Device description
Medisize Breathing Circuit Neonatal, 72 inch(180cm)
Published
2016-10-07
Public version status
Update
Distribution status
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
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18717146000335PackageGS110In Commercial Distribution
28717146000332PackageGS14In Commercial Distribution
08717146000338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1871714600033518717146000335
2871714600033228717146000332
08717146000338087171460003388717146000338

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient, typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are also devices typically employed in the circuit but may not be a part of this device. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612649217604ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217628PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217642ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217666ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217680PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217703PEDIATRIC ULTRA FLEX®King Systems CorporationCAI2026-08-21
00612649217727ADULT ULTRA FLEX®King Systems CorporationCAI2026-08-21
06923980116179N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116186N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116193N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
06923980116209N/AGaleMed Xiamen Co., Ltd.CAI2026-08-19
0503026717028922MM SMOOTHBORE BILEVEL BREATHING SYSTEM FOR NKV-330 WITH MONIT. LINEIntersurgical IncorporatedCAI2026-08-18
14896138016692inspired™VINCENT MEDICAL MANUFACTURING CO., LIMITEDCAI2026-08-05
04719874956547Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
04719874956554Create BiotechCREATE BIOTECH CO., LTD.CAI2026-07-16
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10889483591666Vital Signs™AIRLIFECAI2025-02-18
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10889483593752Vital Signs™AIRLIFECAI2025-02-18
10889483585627Vital Signs™AIRLIFECAI2025-02-17
10889483585801Vital Signs™AIRLIFECAI2025-02-17
10889483584699Vital Signs™AIRLIFECAI2025-02-11
10889483592175Vital Signs™AIRLIFECAI2025-02-11